Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Room 705A
Washington, D.C. 20201
Call to Order and Introductions, Review Agenda - Jeffrey S. Blair
Development of Recommendations for Medical Terminologies
MR. BLAIR: My name is Jeff Blair. I am chair of the Computer-Based Patient Record Work Group, which is a subset of the Subcommittee on Standards for the NCVHS, National Committee on Vital and Health Statistics.
Good morning, everybody. We have got a full day and a little bit more, beginning to get into the issues related to uniform data standards for patient medical record information and the electronic exchange of that information.
Let me just in perspective for those on the Internet and for those that are joining us right now in the hearing room that this particular work group has responsibility for reviewing and studying the adoption of uniform data standards for patient medical record information and the electronic exchange of that information.
In that process we developed a work plan about a year and a half ago and we have been executing that work plan. We have had hearings now back in December of 1998, March, May, June, September and October of this year, gathering information on uniform data standards for patient medical record information. And in this particular meeting, our focus is going to be on reviewing an outline for the report to the Secretary, which is due by August of next year and building a conceptual agreement on that outline, as well as reviewing the issues and recommendations that would fold within that outline.
To put this a little bit more in perspective, the information that we agree on during today and tomorrow will be folded into the first draft of the report to the Secretary, which will be reviewed in the conference call on January the 10th of next year.
We would update that and then the second draft would be reviewed in our next meeting, which is January 31st and 1st. And then we would update that again and the third draft would be reviewed with the full NCVHS committee on February -- I think it is 23rd and 24th of this next year. We would get their critiques and then we would wind up taking the report to other interested parties within the Department of Health and Human Services and maybe some other agencies, like the Veterans Administration, Department of Defense, so that we could update it for final approval by the NCVHS by June of next year so that it could be presented to the Secretary in August.
Given that framework, let me go through two other things here. First, I would like to introduce everybody and then we have another one or two items of business before we actually begin. So, why don't we go around the committee -- to the committee members and the staffers and then, as well, we would like to have anybody else in our room also introduce themselves.
I am Jeff Blair of the Medical Records Institute and chair of the committee.
DR. COHN: I am Dr. Simon Cohn. I am the national director for data warehousing for Kaiser Permanente, a member of the committee and the chair of the Subcommittee on Standards and Security.
MS. FYFFE: I am Kathleen Fyffe. I am a member of the committee and I serve on the Work Group for the Computer-Based Patient Records, as well as the Subcommittee on Security and Standards. And I work for the Health Insurance Association of America.
MS. BEBEE: I am Suzie Bebee from the National Center for Health Statistics and I am staff to the CPR Work Group.
DR. YASNOFF: Bill Yasnoff from the Centers for Disease Control and Prevention. I am staff to the committee.
MS. AMATAYARUL: Margaret Amatayarul(?) and I am contract to the committee, work group.
DR. FITZMAURICE: Michael Fitzmaurice, liaison to the National Committee on Vital and Health Statistics and co-lead staff to the Computer-Based Patient Record Working Group.
MR. MAYES: Bob Mayes, Health Care Financing Administration, co-lead staff to the Computer-Based Patient Record Working Group
MR. BLAIR: Do we have others in the room that could come up to a microphone to introduce themselves?
DR. FERRANS: Richard Ferrans with the Department of Veterans Affairs, staff to the work group.
MS. MYOSEK: Janine Myosek(?), editor of IT Health Care, strategist for Aspen Publishers.
MS. ADLER: Jackie Adler, NCHS.
MR. BLAIR: Okay. Thank you.
Okay. If you take a look at the agenda for today, you will observe that the first item of the agenda is to take a look at the outline or overview of the report, the conceptual outline. And you should have copies of those handouts in your packets.
Margaret did an excellent job of pulling that together for us and -- Margaret Amatayarul.
Then after that, we are going to have sessions, as you would see that they would break out, which reflect the focus areas and the issues and recommendations within each focus area, that would go the rest of the day and then Dr. Cohn has indicated that we would also have a couple of hours tomorrow morning to finish up on the issues and recommendations within those focus areas.
Then we would be getting on to the full subcommittee meetings that Dr. Cohn would chair tomorrow.
Before we begin, I think that now that we are starting to discuss our recommendations, it is appropriate that I wind up indicating those areas where I have associations of any type or form that might have a reflection on these deliberations. I just -- also it was very helpful. I wound up receiving this last week in the mail, the document for special government employees, which we are as a member of this committee, with the ethics rules and I read through them. So, that was very helpful for me to sort of understand where things lie.
So, let me just mention a few things, associations that I have, before we even discuss things. No. 1, three years ago, when I was an IBM employee and doing consulting, I had a consulting engagement with the College of American Pathologists, which was a six month engagement. So, that was something where IBM, at least, earned income as a result of my consulting activities -- that was three years go -- College of American Pathologists. They, of course, are the ones that are producing SNOMED-RT.
I have had no relationships or, you know, financial or other connections with the College of American Pathology since that time. I have been a member of HIMSS, Health Information Management System Society for over ten years. I have been a member of the American Medical Informatics Association for probably about as long.
I have been a member of HL7, Health Level 7, the standards development organization, for probably about five or six years. I don't have any elected positions there, no financial connections. And I have been a member of the American National Standards Institute Health Care Informatics Standards Board for, gee, I guess, since its inception, about five or six years ago.
I am now on the executive committee of ANSI
HISB. I do not receive any remuneration from ANSI HISB. I think I have covered any areas where there might be a conflict of interest or a perceived conflict of interest before we start.
I think Simon has some comments that he would like to add.
DR. COHN: Yes, Jeff. Thank you very much.
I actually think that in view of the fact that we are going to start with the recommendations that in the interest of fair disclosure, that everyone who is here and probably members of the work group who come in late should probably all be asked to do basically what Jeff just did.
I would say that is both for work group members, as well as support staff, just identifying relationships, involvements, if there is any fiduciary or financial issues associated with any of the code system, standards developers or others that we may consider, I think it is time to just disclose those.
Having said that, I will take a moment and do that myself. As I think all of you know, I am with Kaiser Permanente. I am a member of the CPT-4 Editorial Board for the AMA, representing managed care. This is not something that I receive financial remuneration for. I am a member of the National Uniform Claims Committee, representing the American Association of Health Plans; again, not something that financial remuneration is received for, and a member of the ANSI Health Care Informatics Board, where I represent Kaiser Permanente. Again, that is a membership and I have no other active role with HISB currently.
I was a member of the executive committee for the Computer-Based Patient Record Institute, though no longer have an affiliation with them and I am currently a member of the American Medical Informatics Association.
I am sure there are other things that I just can't remember, but that is probably a good start.
Kathleen.
MS. FYFFE: This is Kathleen Fyffe. I am employed by the Health Insurance Association of America and in that capacity I represent HIAA on the National Uniform Claim Committee, the National Uniform Billing Committee and the Work Group for Electronic Data Interchange. And on the WEDI group, which is the Work Group for Electronic Data Interchange, I am a member of the executive committee.
My work for the NUCC, the NUBC and WEDI is work that I do not receive compensation in any way for. I think that does it.
MS. BEBEE: This is Suzi Bebee. I am with NCHS. I am a member of the American Medical Informatics Association and as an NCHS employee, I am also an alternate to ANSI HISB. I am also a member of HL7 and X12.
DR. YASNOFF: Bill Yasnoff from CDC. I am a member of the American Medical Informatics Association and its predecessor organizations, as far back as I can remember. I am a fellow of the American College of Medical Informatics since 1989 and serve on the nominating committee, which nominates officers for that organization.
I do have an outside activity with an organization called Provider Advantage Northwest, which I began before my federal service and which has been approved for me to continue. Basically, prior to joining the Federal Government, I was involved in an SBIR, Small Business Innovation Research Grant project, designed to reduce hospitalizations from adverse drug reactions by giving providers information about the prescriptions that have been filled by each of their patients, delivering that information either in electronic form or -- in electronic form on line or by fax and that currently is underway as a Phase 2 SBIR at the University of Pittsburgh, where there is a clinical trial, which I effectively serve as medical consultant for.
MS. AMATAYARUL: [Comment off microphone.] I am formerly the executive director of the Computer-Based Patient Record Institute and when I was participating in that group, I was a member of the ANSI HISB. I am a fellow in the Health Care Information Management System Society and a member of the American Medical Informatics Association, the American Health Information Management Association and HL7.
I have been invited to serve and have accepted the invitation from the College of American Pathologists to serve on their Standards Development Committee. I am chair of a subcommittee on electronic health records systems functionality, standards for ASTM, E31 -- E31.24 -- and I am a member through affiliation with the Boundary Information Group of WEDI.
DR. FERRANS: This is Richard Ferrans. I am a member of AMI and also of HIMS. I currently do not do any work with any of the standard development organizations, revolving around medical terminology or message format standards. I do participate in the Government Computer-Based Patient Record Project, both at the executive committee level as staff to Dr. Kolodner and also in the Subject Matter Expert Group. I am also the president and founder of a private information technology company, Riptide Technologies. Currently, they build information systems that are open architecture and employ general health care data standards.
I also serve as chief of medical informatics for LSU Medical Center.
DR. FITZMAURICE: This sounds like confession.
I am Michael Fitzmaurice, senior science advisor for information technology to the Agency for Health Care Research and Quality. I am a member of AMI and a fellow of the American College of Medical Informatics, a ANSI Health Informatics Standards Board founder and continued supporter of HISB.
I am a liaison to the -- a government liaison to the AFEC(?) Executive Board, which is one of the three covered entities in HIPAA. I am a member of a committee of the American Association of Medical Colleges, Committee for Better Health, Year 2000. I am paid for none of these. My full salary comes from the Federal Government.
MR. MAYES: Captain Robert Mayes from Health Care Financing Administration. As the director of the Information Systems Group in the Office of Clinical Standards and Quality, I or my delegated staff represent the Health Care Financing Administration in a broad group of clinically focused standards activities and other organizations. These include the ANSI Health Informatics Standards Board, the work that the National Committee on Vital and Health Statistics in this work group do, the HL7, ASTM, X12, ISO-TC215, ISO-JTC1, SC32, the Government Computer-Based Patient Record Project, probably a couple of others that just don't come to mind directly.
We, obviously, also deal directly with the American Medical Association, with the American College of Pathologists. We are responsible for the HCPC codes, not my particular group, but us as an agency. I either have individual membership or am responsible for the corporate membership in all those organizations for Health Care Financing Administration.
My total salary is paid by the Federal Government and I participate in all of these as a federal employee.
DR. FITZMAURICE: Jeff, could I make one addition?
I am also a member of the ISO -- a representative to ISO-TC215 and to the U.S. TAG(?), to the Technical Committee 215 on Health Informatics and a supporter of the U.S. TAG meetings.
MR. BLAIR: Thank you, Michael.
Simon, Dr. Cohn and I had a couple of conversations before the meeting and in addition to our true confessions to start off this session, which I think is appropriate and informative, the other thing that Dr. Cohn suggested -- and elaborate on this if I don't represent it correctly -- is that we are about to get into a discussion now of what would be the role of the Federal Government to assist, promote, enhance uniform data standards for patient medical record information and the electronic exchange of that information.
Dr. Cohn suggested that it might also be of help if the two senior advisers to our committee, Michael Fitzmaurice and Bob Mayes, might just give us a very concise, brief recitation of the ways in which the Federal Government might be able to be a catalyst to facilitate coordination, development, acceleration of standards.
Simon, did I say that the way -- or did you want to -- that is fine? Okay.
Michael, could I ask you to maybe just give us an idea of the choices that we have as we start to go through these deliberations on recommendations?
DR. FITZMAURICE: My pleasure, Jeff.
As part of the Federal Government in giving advice to the Federal Government, we need to look at what tools does the Federal Government have to bring about changes or continue good things that are happening with regard to patient medical record information and standards for it.
Let me start in with, first of all, the government has the power to convene. The government has the power to finance. The government has the power to tax and to regulate. Now, under the convening rule, the government can hold its own conferences, work groups, focus areas, set up its own national advisory committees under the Federal Advisory Committee Act.
The government may support through grants and contracts convening of other parties, such as national associations, academic organizations or individuals who qualify for grants or contracts to support those conferences.
The government has the power to regulate; that is, the government may within the scope of authority given to it by Congress may pass regulations and penalties for violating those regulations that carry the weight of law and are most often enforced by the Department of Justice or the Department of Justice may delegate the organization, the federal agency that has direct line authority for the regulation.
The government has the power to tax. That is not taken lightly and that authority comes directly from Congress. But within the power to tax, the government also has the authority to adjust those taxes; that is, to provide taxing incentives for encouraging the public good. For example, it might forgive some tax that is due as a result of some activities that otherwise would have income tax. The government might adjust a depreciation schedule for capital equipment that is purchased for the benefit of the public good.
The government might allow a write-off against taxes for particular training programs that also influence the public good. So, let's see. We have got the power to tax, the power to regulate and the power to convene, the power to finance.
The government can put out requests for contract proposals. The government can put out requests for grant applications or simply -- with money attached to them or requests -- or public announcements of interest in funding, which is a general announcement.
These requests for proposals, these requests for grant applications often carry with them an indication of the amount of resources to be devoted to a particular activity. In the case of a request for proposal, you have to specify a scope of work and then it is competitively bid and awarded usually to the lowest cost bidder. There are occasions where a sole source contract is appropriate for the government. There has to be public announcement of that and a public case made for a sole source contract.
Grant programs are authorities given to specific agencies. Not all agencies have grant programs in the furtherance of their missions. Those grant programs may be used to further the public good, either to promote research or demonstrations, evaluations, pilot projects that further the public good.
I think I have covered the gamut, but I would leave it open to Bob to add to that.
MR. MAYES: Well, I would add, it is actually somewhat of an extension of perhaps all of those is that the government actually is itself a provider and consumer of health care. So, although it may regulate buying other things, it also acts as perhaps an example, sometimes on a very large scale, of the benefits or the pitfalls that would apply to any organization, whether they be public or private.
The other thing to remember and I think actually I wanted to bring it up as we got into the report is that the government itself, believe it or not is usually responsible for complying with the same regulations and other activities that it forces on the rest of society. And this offers up some opportunity, a very good example of that and one that I think we should include in the report is the National Technology Transfer Act. There is another "A" in it. I can't remember what the second "A" is, but in any event, this is recent legislation that actually requires agencies of the Federal Government to report to the Department of Commerce annually on their use of standards in their operations.
The interesting thing is is that they are supposed to try to use open, publicly-developed standards out of the private sector, rather than their own developed standards out of the private sector rather than their own developed standards and they now have to justify why they are not using those standards, why they would be using, for instance, a mill spec standard or another standard.
So, I think that that is a driver within the government that may, in fact, actually influence these other activities in the sense of the government as a consumer or as a regulated entity itself. That is probably fairly significant because this idea of standards goes way beyond just what many people thought of standards as, you know, how many lumens come out of a light bulb or how thick is a piece of plastic that you use here.
What we are beginning to see as completely relevant to this report is that we are now looking at things like the standard -- the development of standard performance measures in health care. By extension, if you have got a standard performance measure, you need to have a standard way of capturing some information to see whether you have complied with it, which then moves the data and then moves down the chain into systems.
So, that act, potentially, could have very significant impact in drawing in parts of the Federal Government that hithertofore have not really seen themselves directly impacted by standards, per se.
So, I just wanted to say we also -- we act as a large consumer and as a regulated agency, ourselves, which has an impact.
DR. COHN: I actually have a couple of questions for both of you and I wanted to follow up a little bit on the regulation. You had commented first of all that Congress passes regulations and in my -- well, not being a lawyer, it is very clear to me based on the process we went through a couple of years ago --
DR. FITZMAURICE: Congress passes the law and then the agencies write the regulations to enforce the law.
DR. COHN: Right, but it appears to me -- and I want to explore this a little further because some of this bears on what becomes recommendations to the Secretary and what become legislative proposals, that there appears to be some discretionary authority that the administration has in relationship to regulations.
Can you provide any insight into that? Is that -- am I overstating it? I am not a lawyer. So, I need a lawyer's help on this.
DR. FITZMAURICE: Certainly when the Secretary promulgates regulations, the Secretary of any agency, he or she has to look at the scope of the law and how that matches with the scope of the regulation, decide what is feasible to regulate and to enforce and then also the scope of coverage; that is, doing what applies.
Again, there is a question of feasibility. There is a question of burden on the private sector, as well as a question of burden on the Federal Government. To that end, an impact analysis must be prepared for each regulation that is expected to have an impact of greater than a hundred million dollars.
So, there is a breadth of discretion as to how tight, how loose, how large the penalties are for any regulation. Sometimes regulations are put out to be as a guide, not to be as a punitive measure.
MR. MAYES: If I could just add one comment to that, obviously, the regulation has to be within the scope of the particular department or agency's mission, described and funded mission. That means for an example that Health Care Financing may make a regulation that really only extends to Medicare, perhaps through its involvement in Medicaid. But that by itself may be a large enough critical mass to impact beyond the actual regulations.
The regulation may only apply, for instance, to providers who participate in the Medicare program, but given the fact that many, many, many, many providers in the country participate in that program, it could well have impact beyond it. And those tend to actually get much more examination and much more thorough work than a regulation that might impact only a small segment of the economy.
DR. COHN: Can I ask a follow-on question here, Jeff?
Just to go a little further into the regulation piece -- thank you both for clarifying that because, Bob, you actually answered by second question, which was, you know, the aspect of HCFA as very large purchaser in the economy.
Do all regulations have to go through an NPRM process, such as we have just been through? If so, what is the time -- what is an efficient time frame for that to occur that we could take into consideration if we were to propose anything by that route?
DR. FITZMAURICE: Difficult question to answer. The general answer to your question is "yes" and since I am not a lawyer, I don't know the exceptions to every regulation having to go through the notice of proposed rulemaking process. But that is a matter of the public administration's act. The public must be given notice of the regulations.
The time that it takes depends upon how much clearance it has to have. Normally, within the department, let's say a HIPAA standard, for example, is developed and it is cleared through every agency under the Department of HHS. It then goes to the -- is cleared through the Office of the Secretary. It is cleared through OMB and OMB sends it out to all of the other federal departments for their clearance; that is, for their approval of it and their suggestions and comments for changes.
It comes back. It is revised. Finally approved by OMB, finally approved by the Secretary and then published in the federal record. It can be done on a fast track if there is a national urgency and a sense among all the agencies that they must get it done quickly. It can be held up. I should say that there is a time period, usually 60 days after publication of the final regulation that Congress can come in and say, no, that is not what we had in mind.
So, that is a time period that must be accounted for as well. It is often not a fast process. It is a deliberative process, a consensus process within the government and in several different steps, an opportunity to obtain and a necessity to obtain comments from the public outside of the government.
MR. MAYES: If I could add just one extension to that because what happens is, particularly for fairly broad regulations, the actual implementation specifics are usually not spelled out in great detail in the regulation itself, particularly if they are implementation details that may, in fact, change over time due to technology changes or other things. And they are usually put in the form of a manual or some other guide that acts as the fleshing out of the reg.
Those can be changed. Those don't have the same process of change as long as there is a general feeling that whatever changes in that manual issuance isn't going to fundamentally change what is in the regulations.
A good example in the HIPAA regulations would be the code set issue and the ability that it was decided in the reg that, yes, this is the code set, but as long as you keep this standard -- whatever ICD-9 code set, the ability to add and delete codes is not a regulatory process. It is a process that does -- there is a process but it is not at the same level of having to require clearance. The relevance there is when we look at the recommendations in the report, we need to think to some extent, you know, what level are these. Are these regulatory issues or are these lower process level issues that might be able to be handled either as part of a reg or as part of existing operations of the government, realizing there is a big difference now on the regs.
MR. BLAIR: Could I do this, if I may, because we have taken more than half of the time we had scheduled to discuss the outline for the report on these -- this has been a very important topic and I think we needed to do that, but if there are additional questions with respect to the government's role on regulations, could I ask that you get with Bob or Michael during the break and later on tomorrow if these are things that need, you know, to be addressed with the group at large? We can do that. Because I think we have got only 20 minutes in this segment to discuss that report.
DR. COHN: Jeff, if I may respectfully disagree, I think that this is a critical discussion to allow us to figure out what the recommendations should be.
Now, I personally don't have any other issues, but I am curious -- Margaret was our consultant -- I am actually curious what questions she may have had that may in her view reflect on our recommendations or otherwise. I apologize, but I really think we need to flesh this one out.
Margaret, did you have an issue that has pertinence to the --
MS. AMATAYARUL: Yes, I just had a follow-up question with regards to the implementation guidance. And that was what is the role of implementation guidelines developed by industry; for example, the official coding guidelines, the guidelines for X12N standards, the guidelines that WEDI is developing for security, those kinds of guidelines?
DR. FITZMAURICE: Margaret, those implementation guides are adopted into the regulation. The regulation referred -- the draft regulation has referred to a specific set of implementation guides by number, like 4010, if I remember. But that might not be the right number.
They are a part of the regulation.
MS. FYFFE: 4010 is a version of --
DR. FITZMAURICE: But that the version. There is a version referenced in the regulation. So, that becomes adopted as part of the regulation.
MS. FYFFE: I don't think we have answered your question.
MR. MAYES: It is a little broader than that because in the HIPAA legislation specifically -- and this is actually somewhat unusual, an explicit requirement was there for a standardized implementation guide and this is what Mike is referring to is that what was chosen was this particular version of, say, for instance, the 837. I think that you are referring the sort of industry guides, like the AFEC(?) one on security is not referenced in the legislation.
That is actually the more common way it happens is that the legislation or the regulation speaks to a certain level of details and then it is left to the private sector or to the effected parties, which would include public sector as well, to develop an implementation or implementation strategy or strategies to comply with the regulation.
Those do not have the force of law. They are simply consensus approaches that may or may not be broad consensus, saying, you know, here is the regulation. We have gotten together as an industry or part of an industry and said to help our industry out, we have come up with a way of complying with the regulation within the context of our industry or our part of the industry.
DR. FITZMAURICE: That is right, Margaret. And to the extent that a manufacturer, a private sector organization wants to know if it is compliant or not, often the industry will set up these informal guides, these non-regulatory guides and set up a certification process, will run the certification process by the government so that the industry would self-certify that it is compliant with the government regulations and then the government would deem if it finds it appropriate, deem that certification process.
An example of it is the certification of JCHO or the conditions of participation for Medicare providers. But the government does not have to deem an organization's informal guidance as if you follow this, you are in compliance.
MR. MAYES: Ultimately, it comes down to a legal discussion. I mean, if no one complains, if you will, then it is really not an issue and then if they do, it ultimately gets to a legal decision as to whether or not the regulation was complied with, regardless of all the other ways that you might do it.
I just bring that up because that is a -- you know, just because something isn't regulation doesn't -- as we all know, doesn't necessarily mean -- it can be tightly or loosely applied and that is really dependent upon the subject of the regulation and on the consequences of complying or not complying with the regulation.
And as the purpose, as Mike said, some regulations are not punitive or not directive in nature. They are guiding in nature. In that case you would have a much different type of implementation direction guide than you would for something that is very directive, that says, you know, this is the way you must do it. Railway tracks must be x number of miters wide, because if not, we would have train wrecks.
DR. FITZMAURICE: I would just add to what Bob said, that we are very much in favor of voluntary compliance, voluntary certifications. We are out to address commonly recognized problems in the best way possible and often it is the industry that recognizes the best and the most cost effective way of addressing these issues.
MR. BLAIR: Okay. Let me extend the time that we have for this -- because I think we are going to need more time than 20 minutes to go through the outline here. So, if we ran until 10:15, hopefully, we will be able to kind of cover these things.
To try to see if I could set it up for you a little bit, if you look at the document that, you know, has Margaret's cover page on it, let me just give you an idea of that first section, which is the outline for the concepts that would be within the front part of the report, including the executive summary, the purpose, the scope, the general rational and that summary of the focus areas.
This is prior to the details of the issues and recommendations, which is the bulk of the document. Okay?
Margaret, we didn't get a chance to talk beforehand, but -- you know, I can't see whether you are there with your computer to do updates to it? Okay.
MR. MAYES: She is all set.
MR. BLAIR: Put this aside.
With respect to this, let me just sort of give you the thoughts with respect to this first section. That executive summary is simply derived of the major points that are in the introduction and in the body of the report. The purpose of the report, I think, speaks for itself. The scope is important in this context because there was a lot of testimony that came up that referred to issues that, quite candidly, went beyond the scope of the report and if we wind up allowing ourselves to go beyond the scope, it will be very difficult for us to stay on target and stay focused.
So, we want to make sure that we are clear about what the scope is. The other piece, the general rationale -- excuse me -- the introduction section, and I kind of skipped around a little bit here -- excuse me for getting out of here -- the background piece, if you glance through the topics within the introduction, which has the background, you will see that it is intended to take you through the challenges within the health care system overall and bring you just simply down to the point where there is a need for information systems to assist. Okay?
The next piece, which goes beyond that, is in the general rationale, where it winds up saying, okay, if health care information systems can assist with health care problems overall, then what are the issues, what are the barriers, what are the impediments that need to be addressed in that piece, the general rationale piece, brings you from health care information systems down to the role of uniform standards for patient medical record information.
Given that to sort of help you put that in context, let me turn this over to Margaret to ask if there are any questions or updates to each section. Margaret, is that okay or should I --
DR. COHN: Maybe I just need some clarification. Are we going through the sections now or are you just talking about the outline?
MR. BLAIR: The first -- and I am not sure whether it is two or three pages --
MR. MAYES: Yes. It is titled "The Outline of the Report." And there are sections in that executive summary, background and that sort of thing.
MR. BLAIR: Right. It would take this section in our agenda calls for us to review the outline of the report, which includes the executive summary, the introduction. Within the introduction, there is, I guess, five or six sub-items in the introduction, which include the background, the purpose, the scope, the general rationale and just the -- you know, the summary of the focus areas, what they are.
Then the body of the report is what we will begin to review after the break. The body of the report includes the issues and recommendations. That is where we would get into the general -- the guiding principles and stuff like that. Okay?
Let me step it through. On the first price, the executive summary, is there any comments or questions or concerns about what would be in the executive summary?
DR. COHN: I guess I am presuming the executive summary is being written after we write the report.
DR. FITZMAURICE: So, we are probably talking about the outline of the report as we talk about the executive summary.
MR. BLAIR: Yes, that would be correct because it would be a derivation of what we have in the introduction in the body.
DR. FITZMAURICE: So, Jeff, you are asking about the first paragraph under Roman numeral I, executive summary?
MS. FYFFE: I just have one comment. This is Kathleen Fyffe.
There is a kind of a tension between having a brief executive summary and an informative executive summary, given that most people won't read beyond the executive summary. So, we do want them to read the executive summary. So, I somehow think that maybe optimal is three pages, but no longer than five pages for an executive summary. I am just throwing that out for now. We don't know how long it is going to be, but it is going to have to stand on its own.
MR. BLAIR: I would agree with your observations. I don't hear any objections to that. Is that correct with those sentiments? You know, three to five pages. We want to make sure that it is both concise, but that it is informative enough that --
MS. FYFFE: Stands on its own.
MR. BLAIR: Stands on its own. Right.
Any other observations?
DR. FITZMAURICE: Jeff, I would like to say that I think it is great to get -- it leads us in the large overview to where we are, what the general broad problems are. The one thing I would add and I actually have notes to edit later on under general rationale and major barriers, but also a mention in here of errors in medicine.
There has been a large and well-received, well-publicized report by the Institute of Medicine on errors in medicine. But I think we should reflect the role that patient medical record information can play in that later on in this outline, but I would foreshadow it with one of the bullets here, stating that this is a major problem that can also be addressed by this report and that will also be addressed by this report.
DR. FERRANS: This is Richard. I certainly echo Mike's comments about that. Since there was so much testimony regarding the specifics and there is a nice body of literature there, this is timely and relevant.
The other thing that I was hoping and I didn't see any mention about measuring quality of care in here and in general the difficulties that have occurred in people actually trying to do that. Somehow if we can put this in here since that seems to be another variable of an issue.
MR. BLAIR: The ability to measure quality of care.
DR. COHN: Richard, if I could sort of second that because to me one of the key strands here is we are talking about information systems, but we aren't actually talking about the data and what we would use it for generally. And I think quality of care is one. Understanding best practices and evidence-based medicine, I think that is probably a bullet here that ought to be a high level issue.
Robert.
MR. MAYES: I was just going to say actually I think that we have a couple of bullets. The error thing is actually in one of them. It is just sort of buried in a bullet at the end of the report.
But I think really that bullet, the third bullet that talks about the not improving health care statistics and the next bullet, which talks about the improving performance could probably be reworked. I think they are fundamentally talking about quality of care. Maybe we ought to use those words specifically versus just --
MR. BLAIR: Kepa Zubeldia, you have joined us here. Would you -- one of the things that we did when we went through our introductions was we also -- because we are discussing recommendations at this point, we just very briefly mentioned some of the organizations that we are affiliated with and whether or not we received any funding from them. So, would you just take just a minute to introduce yourself and indicate the affiliations that you have.
MR. ZUBELDIA: I am Kepa Zubeldia. I am vice president of technology for ENVOY Corporation. I am also chairman of the board of Arkanos(?), which is a specification authority licensed in Utah.
MR. BLAIR: Any standards organizations that you are a member of and whether or not you received any remuneration from any of them?
MR. ZUBELDIA: I am a member of X12 and a representative for Health Care. Also, I am obligated with ENAC(?) and a commissioner of the accreditation commission of ENAC and vice chairman of AFEC, but I do not receive remuneration from any of them.
MR. BLAIR: Kepa, we are in the process of going through the outline for the report and right now we are in the introduction section under the background and there was a couple of suggestions of points to strengthen that section.
Are there any other comments or suggestions with respect to the background?
DR. FITZMAURICE: Just a suggestion that costs have risen from 6 percent of the GDP to almost -- I think it is 14 percent, but we can clarify that later.
DR. YASNOFF: This is Bill Yasnoff.
I think this relates to some of the other comments. I wonder if it might not make sense to combine the background and rationale sections or maybe move the rationale section to be after the background because in reading this, this is kind of a general background statement and then we go into this issue of standards. Coming at this without prior knowledge, I am asking the question, well, problems are these people really trying to solve here. I am not -- I don't understand the motivation and that is why -- I think these issues related to errors and quality and some of the other issues that are in the rationale section really need to be closer to the beginning.
In other words, I think the way the report might flow better is if you say, well, obviously, health care is expensive. It is growing. It has been slow to adopt information technology, but there are all these problems. There are errors. It is difficult to measure quality. It is difficult to exchange information. There are tremendous costs in integrating systems, creating huge overheads in an already overburdened system, et cetera, et cetera.
Therefore, Congress in its wisdom passed this law, which led to this study and we are going to try to fix those problems.
MR. BLAIR: Bill, if we did that, if we moved the general rationale section up so that it immediately followed the background, which I think is what you are suggesting, then where would you put the statement of purpose and the scope statement?
DR. YASNOFF: Right after that.
MR. BLAIR: Right after that.
DR. YASNOFF: In other words, essentially the flow of it is -- now we are not talking about the executive summary, although presumably the executive summary would mirror this, is that you say, you know, health care costs but the system has many problems, as evidenced by problems with quality. There are errors that really have to do with system problems that are costing people their lives.
There are huge costs in putting together incompatible systems. We are not able to monitor the health of the public effectively because different terms mean different things in different systems and so on.
MR. BLAIR: Could we just get people's reactions to Bill's suggestion that we move the general rationale section so that it follows the background and we move the purpose and the scope so that it follows those two sections?
MR. MAYES: I like it in general. I would sort of still keep them somewhat separate and I would connect them with the fact that the background paints a picture of the general state of health care and some of the problem areas. I think there needs to be a statement in there that, you know, many of these problem areas really are due to lack of communication, lack of the ability -- I don't know if you want to use those exact words, but to effectively share information.
Now, why do we have that lack? Well, we have that lack because there are these big barriers. It is expensive. All the things that are in the rationale. Then we follow that so, therefore, you know, Congress has asked this committee to examine this and see are there recommendations for how we meet that -- how we deal with those barriers and, therefore, directly impact this committee.
DR. YASNOFF: So, Bob, what you are arguing for is to still have a separate background and rationale section, which -- I have no problem with that, but you are --
MR. MAYES: Whether you tie to them separately, I think that they should be -- here is a general view of the problems. Here is what we think the fundamental underlying issue is, which is inability to effectively share information. And then here is why -- why do we have this problem? If we all can agree that the problem is we can't share information, why haven't we solved it before?
The rationale as laid out here gives you some very relevant reasons why that has not been the case, but we feel and Congress has felt that maybe the time has come to reexamine those or to examine ways that we might be able to address them. Then with the scope is -- the final thing is, by the way, this isn't just the entire world. We are fundamentally looking at this piece and then you go into the body of the issues.
MR. BLAIR: If we were to realign them that way, I think it gives us an opportunity to do something slightly different because of what you just said, Bob, which is that if we end with the scope, then if you notice the note that is at the bottom of the general rationale section, that relates to the other issues. Should that note all then within the scope statement, instead of within general rationale?
MR. MAYES: I would think so.
MR. BLAIR: Move the note within the scope section.
DR. COHN: I didn't understand. What was your suggestion?
MR. BLAIR: From the suggestions for modifications that we have so far is that we take the general rational section and that follows immediately to the background section.
Now, Bob was pointing out that when we have a flow like that, one of the things that would be logical is if that then was followed by the purpose and the scope and if that is the case, Bob was mentioning that when we get to the scope section, that might be the appropriate place to indicate --
DR. COHN: Where the scope issues are.
MR. BLAIR: Where we had the note, which was the last item in the general rationale. We would now move that note issue down to scope.
DR. COHN: Yes, and since that is a scope issue, I --
MR. BLAIR: It is not a note. It is part of the scope. Right?
DR. COHN: The only addition that I would make to any of these comments -- and I don't think we need to spend a tremendous amount of time with organization because we need to see it in another version. Maybe, depending on how long the background and these general rationale major barriers is, we actually might want to start with the purpose and it might be useful for people -- normally, most people are only going to read the executive summary anyway, but, you know, it might be sort of a little awkward to go three pages without having an idea of what the purpose of the report is. You might want to split up the purpose and the scope to the beginning and end.
So, it is just a thought. I mean, I --
MR. MAYES: We could always restate that. Yes, I agree. I think that it would make sense to open up the report with the fact that Congress is -- this law has been passed and we are supposed to do -- I mean, a very sort of terse purpose statement, just really a restatement of the charge. It is almost a charge.
Then, I mean, one might either expand that in a separate -- you know, following the other two or really just include it in the scope at the end.
DR. FERRANS: Just a sort of footnote to that. If you put that in the purpose and you put a very terse why are we doing this, I don't think that the actual -- according to the legislation, that certainly gives what I would say what we are supposed to do, but it really doesn't explain the purpose the way I would --
MR. MAYES: Right. But I think we could restate it twice. You could state that all --
MR. BLAIR: Could I -- because I think I understand Simon's thought on this. Maybe if we just simply began it with the sentence of what the purpose is, quoting the law, and that is within the introduction and then go through the background and the general rationale and then have a separate defined section or tab or sub-item that says purpose, where we restate it more fully. Okay?
DR. FERRANS: Yes, but I guess what I was going to say if we had that one sentence with the definition and then we added a second sentence that said something like because this would have a significant impact upon -- potential impact upon improving quality -- I mean, that would sort of state the purpose and then you go into the background because otherwise people would say what does electronic exchange of health care data have to do with the cost of care or et cetera, et cetera. Sort of lays out at the very beginning to the readers of the executive summary that are only going to read the executive summary why we are doing this and the real reason we are doing this is not to make recommendations.
The real reason is because it would have a --
MR. BLAIR: Profound difference on -- yes.
Bob.
MR. MAYES: Well, I was -- yes, I don't know. I struggle back and forth.
MR. BLAIR: So, you are looking whether to put the purpose first in full or whether to -- I kind of like your idea where you just basically start with a quote almost; you know, sort of like you see at the beginning of chapters in books and things. You have a quote from the law that describes exactly the charge, if you will, and then get into the purpose.
I don't think there is a problem with reiterating it, frankly; I mean, putting it right up front in the terms of more bald language out of the thing and then going through the background and then going into the purpose once again because you need to tie it into the scope, I think, somehow.
Are there other comments or thoughts about whether there should be an early statement, brief, concise statement about the purpose preceding this and then a more complete statement after the background and the general rationale?
DR. COHN: Actually, maybe I should just make a comment because the whole purpose as you have it is only about three sentences long currently and the purpose is really the charge.
MR. BLAIR: Okay.
DR. COHN: And maybe it is -- I mean, we should at least try it and the next version is the first piece within the background and whatever and then I think the scope is very appropriate after that and we should try it on for size. It may not be right but --
MR. BLAIR: Okay. Fine.
DR. COHN: Is that okay?
MR. BLAIR: Yes. Does everybody feel okay with that? Everyone is nodding.
MR. ZUBELDIA: I feel okay with that, but I think that if you do that and put the purpose at the top, then would the quote from the law become part of the background? Then you have those three sentences and --
MR. BLAIR: I think that it is helpful for people to have titles, even if it tends to flow -- we want it to actually flow together, but I think it is useful for somebody to glance through this to wind up saying, well, this is background. This is general rationale. To the degree to which we can write it in a manner that does that --
PARTICIPANT: Okay.
MR. BLAIR: The only other thought that I would have is that my inclination is that if we move the purpose up to the top, in a sense the purpose to some degree does describe the scope, but I do think that it would be important on this to have a separate section on scope and I probably wouldn't want to break up the background and rationale piece and I would be inclined to put that scope section with the expansion of the other issues. I think we would want to mention these other issues and not just omit them.
So, I do think we ought to have a separate section on scope, which talks about the things we are not including as the last section in the introduction. Bob is agreeing with that.
Are there other thoughts on that?
DR. COHN: Yes.
MR. BLAIR: Simon is agreeing.
We all agree. Okay.
MR. MAYES: Can I make one other comment and it might -- this is really perhaps not substantive, but I think it might be interesting. It might be interesting to preface the entire report with a salient quote, for instance, from the IOM study, followed by the exact quote from the law, from the -- you know, from the law sort of saying --
DR. COHN: Which IOM study?
MR. MAYES: On computer-based patient records.
DR. COHN: Oh, okay. Oh, on that one. I thought you were talking about patient safety.
MR. MAYES: Well, that is -- I mean, I am just sort of saying why -- it doesn't matter.
MR. BLAIR: The only thing is if we do that, then we start to blur this issue of what the scope is and people will wind up seeing that the first thing and they will wind up saying this is a report on computer-based patient records.
MR. MAYES: Never mind.
DR. COHN: Can I make as also a general comment about -- I mean, I think we have hopefully talked about the -- which order of things are we in right now. I just want to make a general comment, which I think Margaret has already heard from me, in terms of the general rationale and major barriers.
I just want to remind everyone and I hope that Kathleen Fyffe may have some comments about this also, that one of the major rationales for all of this is allowing increased computerization, but I think there are other threads that we need to be looking at and reinforcing in the issues of general rationale.
I think we have identified some of them having to do with patient care or evidence-based medicine, et cetera, et cetera. But those things can exist and be supported by the standards without computer-based patient records and will just helped by general standardization of information even if you only have pharmacy lab systems X, Y and Z. So, we need to make sure to clarify that.
MR. BLAIR: Could you state that one more time so that we could get that? We -- or maybe I will restate it. You tell me if I am on target.
DR. COHN: Okay.
MR. BLAIR: One of the points that you want to make sure is explicitly stated is that when we are talking about uniform data standards for patient medical record information, that they are helpful in addressing these issues, whether or not there are computer-based patient records. Is that what you are saying?
DR. COHN: Well, I think it is -- it is beyond that. It is they are supportive and enabling to patient based patient records, but they are also enabling to a number of other things going on.
Actually, Bob, maybe you could --
MR. MAYES: I agree with you completely. I actually think that Jeff may have restated in a more forceful manner, which is, you know, again, the fundamental issue if we go back to why we were linking the background and the rationale was we got a problem in sharing information. Now, you know, in today's world, ,we do a lot of sharing over computers, but it is -- the problem isn't that we don't have a whole bunch of computers, because then it is an argument about the business case issues that Kathleen has brought over and over again. The problem is fundamentally how do we share information and that is exactly what you are saying is that if you standard -- if you develop these standards, we are not talking about a computer record here. We are talking about a computer record here. We are talking about developing standards that would allow us to share the information irrespective of technology really.
I mean, it would be beneficial if I write you a written -- handwritten note and you and can still understand what we are saying. So, I think you are saying we need to deemphasize the fact that this -- or need to emphasize that this is not simply a report on how to computerize things. That is an outcome. It certainly supports that and that is obviously going to be very fruitful to use the power of computers, but it is really a bit more fundamental coming up with computers.
DR. COHN: Yes. And actually I think I would almost rephrase this as saying one of the problems is sharing information. Another problem is not having computerization where you live.
MS. FYFFE: So, we are identifying problems independent of the fact that we don't have integrated computer-based patient records.
MR. BLAIR: Correct.
DR. FERRANS: If we were to use illustrations at all, I think a good illustration is laboratory systems. Virtually -- I mean, most hospitals do not have computer-based patient records. All hospitals have laboratory information systems and the exchange of that data, just by virtue of the standard would be something that would be beneficial for a number of reasons.
MR. ZUBELDIA: I think that is in line with the child -- from that law, that says shall study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information. Two different things. Uniform data standards without electronic exchange is the charge of the law.
DR. COHN: And maybe we wouldn't want to necessarily use lab as an example only because lab we should expect to be handled through claims attachment standards. We might want to find another example.
MR. BLAIR: At this point we have really kind of covered this topic area pretty concisely. I think there was apparently a fair amount of consensus, some good ideas to, you know, add to it.
Could I ask you before we close in the next maybe ten minutes, could you please focus on the general rationale section and please look critically to see did we leave out some important points or do we have anything about that section we need to modify or strengthen or --
DR. YASNOFF: Jeff.
MR. BLAIR: Yes.
DR. YASNOFF: Bill Yasnoff.
Some of the points that are further on in the report, some of those issues, in particular, 32, 33 and 34 --
MR. BLAIR: I don't know by number.
DR. YASNOFF: Let me tell you what those are.
Huge cost of integrating systems, development of standards as time consuming and costly and acceptance of standards as constrained by fees or fee structures. Those three issues were identified as being outside the scope of the work group?
MR. BLAIR: No, no.
DR. YASNOFF: That is what it says.
MR. BLAIR: You will find those when we get into the message format standards and the --
DR. YASNOFF: Anyway, that is not my point. My point is that those three issues need to be in the rationale.
MR. BLAIR: I am sorry. Tell me the issues again.
DR. YASNOFF: The huge cost of integrating systems, the fact that development of standards is time consuming and costly and the fact that the use of terminologies is constrained by fees and fee structures.
MR. BLAIR: The last one was the one that we included within the terminology piece, but the first two, I agree with you need to be in the general rationale thing. That was a good catch, but on that last one, the fee structures, let's discuss that, whether or not that is a appropriate for the general rationale or whether you feel like that should be --
DR. YASNOFF: Well, since you have labeled this section "General Rationale and Major Barriers," the fee structures for terminologies is a major barrier.
MR. BLAIR: Since it was specific to terminologies and since we have a section on terminologies, we thought that that --
MR. MAYES: It is most evident to us in fee structure for terminologies, but run time fees as a general -- that is one of the problems with proprietary systems is that they have got you. So, I mean, I think you could make a more generalized comment that, you know, proprietary fee structures or the requirement to use proprietary systems often results in, you know, costs, fee structures, run time fees, other things like that.
MR. BLAIR: Bill Yasnoff, does that capture your thoughts?
DR. YASNOFF: I think that maybe we should be even more general, which is that we have to be sure that the cost of improved sharing of information does not exceed the benefits -- the cost. And so, you know, in some cases there -- at least to the end user, there appears to be a mismatch between the cost and the benefit and also there is this issue that the cost may be allocated to one party; whereas, the benefit is derived by another party and the party that derives the benefit may be the government.
DR. FERRANS: That was the alignment incentives that was mentioned by Paul Tang, specifically.
DR. COHN: Actually, if I can comment, Bill, I actually thank you for bringing this up. I think during our conference call we had in the areas that you have just described identified them as needing to be up in this rationale and major barriers, because that was where the big B issues were going to be mentioned. So, it is good it just didn't disappear.
MR. BLAIR: I think Kathleen has a --
MS. FYFFE: Yes, I have a comment. When we consider who the audience of this paper is going to be, they might know a little bit about the health care industry, but they don't know much about computer-based patient records or the detail of the problems.
Just an observation here, when I look at the background section, it doesn't necessarily tell me anything new. I think that the points that really, really need to be highlighted in the executive summary and early on in this report are the first four impediments that are listed.
Let me just review those. I will be pedantic about this. Okay?
It says, "These impediments include the lack of interoperability among different health care information systems increases the cost of sharing and integrating data." Now,, even if you know nothing about health care or computer-based patient records, to me, that grabs you.
The second one, the lack of comparability, precision and accuracy in PMRI reduces quality of care delivery to sub-optimal levels. I mean, that also grabs me.
Then the next two are also important; the lack of controlled medical terminology impairs the ability to share. That is not quite as easy to understand, but it is still important and then the fourth one, lack of incentives to build and implement information systems that will promote quality follow-up care.
Now, I cannot speak for the audience that is going to read this, but those four points, I think, are very, very important and if they don't remember anything else about the report, I hope they remember these points. Okay? So, food for thought.
MR. BLAIR: Very helpful. Very helpful.
Any other concerns, comments, additions?
Mike.
DR. FITZMAURICE: I have one, Jeff, and that is I will get back to the errors in medicine, IOM report and in general. We talk about the problems with cost, the lack of being able -- the high cost of being able to exchange data that means something right now because we don't have common medical terminology. We need to emphasize that part of the rationale is that errors are occurring and we think that sharing of the information can reduce those errors and improve the quality of care. These then are the steps needed to improve the sharing of information that means something.
MS. FYFFE: Now, actually, Mike, the highlighted point, the lack of comparability, precision and accuracy in PMRI reduces quality of care to suboptimal levels, is that a good tie-in to the IOM report?
DR. FITZMAURICE: It is a good tie-in but I would put it up above as a -- we have these errors in medicine that are causing 44,000, 90 some thousand deaths a year. So, it hits you like we are spending a lot of money on health care, a trillion dollars or the -- it is a basis. It is a substance.
MR. ZUBELDIA: Maybe it could be folded into this point that Kathleen is pointing, this lack of comparability, precision and accuracy is causing errors in health care.
MS. FYFFE: Yes, very much so.
DR. FITZMAURICE: I like those four bullets kind of the way they are. I would put it as a paragraph up above somewhere that lends importance to those bullets. I wouldn't expand them and then lose the impact that they have.
MR. BLAIR: Michael, would you restate that so that -- tell me exactly what you are suggesting there.
DR. FITZMAURICE: I would put a paragraph pretty close to the top of D, "General Rationale and Major Barriers," that explains a problem in the quality of care. And that is there are errors in medicine that result in unwarranted deaths in the United States. The IOM report has several estimates of the number of deaths. This is a striking number, comparable to the cost of health care, compared with the cost in other nations.
Where the cost of health care strikes, this strikes at quality. I don't that we have a number or a report that addresses access, as well. If we did, I would put that right up front as the rationale for why these things are important and then those four bullets are important because they can address cost and they can address quality. We then readily admit quality and cost are a problem.
MR. MAYES: Actually, Mike, I think in terms of the access, we do have the issue on disadvantaged populations and racial disparity. I think that that -- there is a real problem in this country that has been identified and certain --
DR. FITZMAURICE: If there is a way to work that in, then I am for working that in, too.
MR. MAYES: That is another politically very --
DR. COHN: I just want to make a comment and then I want us to move away from this to general quality discussions because if we don't watch out, it is going to get too wordy and we are going to miss the main points. But I am concerned at least just mulling over that the fourth item that we described as a major impediment, which is that there is a lack of incentives to build and implement information systems that will promote quality of care is actually out of the scope of the document, as best I understand.
So, we need to be careful -- I mean, we either need to decide that we want to approach that with recommendations or we want to --
MR. MAYES: That is why I think it is just one of these major business drivers. We will address in the scope section that it is out of scope, but I think it is -- I mean, why is there lack of incentives there? What cost --
DR. FERRANS: If the government has the power to incentivize, in some way I do think it is --
DR. COHN: Okay, but without trying to answer the question at this point, I just want to observe that, you know, this is why the business case issues are important for the recommendations because here we are sitting here going, well, gee, this is a major --
MS. FYFFE: Well, let me beg to differ, Simon. I don't think that the lack of incentives is out of the scope because if you go back to the provisions, it says shall study the issues related to the adoption of uniform data standards, blah, blah, blah, blah. I don't think that is out of the scope to talk about one of the issues being the lack of incentives.
DR. COHN: Well, Kathleen, I agree, but all I am commenting on is in the current document, as we have right now is, I believe, listed as being out of scope, as I understand. There are no issues or recommendations related to it.
DR. FERRANS: The other piece I just quickly wanted to add in here is there is no mention of the financial situation in health care today. I mean, it is a huge that, yes, we all agree, but who is going to pay for this?
MR. BLAIR: I thought that we cover -- is that not mentioned in the background in a couple of places?
DR. FERRANS: Well, in terms of major barriers, I would identify as a major barrier the fact that hospitals are seeing, you know, raise within margins. Health care plans are losing money. So, the people who would pay for these systems, even if they wanted to, even if they recognized the value --
PARTICIPANT: Difficulty of providers with their financial --
DR. FERRANS: That is something to the casual reader will go, yes there is a problem here. No one has the ability to pay.
DR. FITZMAURICE: I would add to what Richard is saying that part of this that we have to address is the role of the government versus the role of the private sector.
Bill Yasnoff mentioned earlier, there may be a problem if the benefits are not worth the costs. I am not sure we want to address or advocate something for which the benefits are not worth the costs. Yet, the social benefits may be greater than the costs. It is just that no one private entity can capture those benefits and thereby fund the costs. So, it is a proper social judgment, a role of the government, to judge that the social benefits are, in fact, greater.
There is a failing in the private sector to be able to capture those benefits. So, as a part of the public good, the government provides them, provides incentives or encourages their development.
MR. BLAIR: Bob Mayes has pointed out to me we are about 25 minutes, you know, past 10:00. Margaret, you have another comment and maybe we would just take one other comment past Margaret and then we will be at 10:30.
MS. AMATAYARUL: I was just going to ask if on page 12, some of the verbiage that we have listed under the issue relating to the national health information infrastructure in the table section, if that would address what you were just referring to? And should we bring some of that forward to the rationale section?
MR. BLAIR: Are you asking me?
DR. COHN: Margaret,, can you repeat your comment? I am sorry.
MS. AMATAYARUL: Yes. I was responding to Richard's comment about how we lack funding in the health care industry. Our margins are slim, et cetera. On page 12, under the issue statement for national health information infrastructure, we talk about cost, lack of funding, the Balanced Budget Act, Y2K remediation and other issues that are confronting the providers and payers, et cetera, today. That could be moved to the rationale section.
MR. BLAIR: Could I inject on this piece. My thought is that, Richard, what you are saying is true. However, there are so many factors that determine whether or not a health care provider can provide care within their costs and uniform standards is only one of very, very, very many.
I sort of feel as if we need to stay directly focused to communicate very directly and I think that if we start going down that thread, it opens up kind of a Pandora's box of other issues, some of which are beyond the scope.
So, I am not convinced that that helps our case. I think it may be a little bit distracting and confusing if we start heading down that path as well.
DR. FERRANS: I guess my point was -- and perhaps it is the view from the field is that when we talk about major barriers, if we don't mention the cost to the people who are paying for the systems to put these standards or whatever into place -- not the cost. Their ability to pay, their current ability to pay.
MR. BLAIR: Again, what you are back to is the cost of the CPR system and if we start going into a business case for a CPR system or a health care information system, we will drown.
DR. COHN: Well, can I make a comment on that because I think it can be looked at in a slightly different way and I think the observation is is that benefits of standardization and benefits of increased electronic exchange --
MR. BLAIR: That is what we have to stay focused on, yes.
DR. COHN: -- benefit different groups of -- in the health care system differently. I think there is a little bit of a comment that is sort of a high level comment in HII recommendation, but I think that our recommendations maybe need to stay focused more on that there needs to be ways to realign those incentives benefits, et cetera, which I think is what you were saying also.
DR. FERRANS: Yes. And if I could just add one other comment to that. The view from the field is that people are unwilling to invest in the absence of standards.
MR. BLAIR: Okay. That people are hesitant to invest because of the absence of standards.
At this point could we take our 15 minute break and then after that then we will begin our discussion of the issues and recommendations for the message format focus areas.
Thank you.
[Brief recess.]
MR. BLAIR: Okay. On this next session -- by the way, this is the NCVHS Work Group on Computer-Based Patient Record Systems for the Internet folks. We finished our break. We are about to on our agenda begin the next section.
The next section is on the issues and recommendations for message format standards. Margaret has spent a tremendous amount of time culling through the previous testimony and the documents and handouts to be able to pull together both the issues and recommendations not only for this section, but for the rest of today and tomorrow.
There is a preface to this and let me refer you to the document that Margaret prepared. Those folks that are here, you will also -- Michael Fitzmaurice has just ran out and made a copy of the guiding principles. Keep that in mind because as Margaret takes us through the preface in terms of how we are going to proceed, we will begin to relate some of the process of how do we arrive at what our recommendations should be related to these guiding principles.
So, Margaret, can I turn this over to you to lead us from this point on?
MS. AMATAYARUL: Okay. The table of proposed issues and recommendations has a preface and there were a couple of points that I think that are important to think about as you review the issues and recommendations. We really hope that you will feel free to make any further changes in the issues. You have already seen them once, but as you can tell, we have already made some changes based on, you know, how we characterized the recommendations.
But basically, the recommendations, what we did was we -- just as we did for the issues, we went through all the testimony, identified every single recommendation that existed and then summarized those. And I have to say that in large measure the recommendations were very broad and general, like "Do good." So, we tried to get them to be more specific and rarely, if ever, did people make recommendations that the government should do, the role should be.
So, we did try to -- in developing the recommendations for your review and consideration, we tried to identify what the role of government would be relative to the recommendation. But in some cases, we actually didn't have a role and we asked what the role maybe should be or maybe there is no role and it is just out there for the private sector to work on.
Simon, you look like you have a question.
DR. COHN: Well, actually, I just wanted to make a comment because I actually think that this was overall good work and I congratulate you and thank you for the hard work I know you and Jeff put into this particular part.
I did however want to comment just to suggest that the work group consider that most of the recommendations are merely jumping off points. The role of the NCVHS is to provide leadership and assistance to the Secretary and one source of that assistance and advice is the testimony that we have received, but it also needs to be the judgment and the expertise of the work group and the overall NCVHS exactly what recommendations occur. So, we should not feel ourselves by where there is universal agreement or where there is lack of agreement by our testifiers.
That is my comment on that.
MR. BLAIR: Let me just add because -- let me prompt you, Margaret, to -- there is a section you have in there in the preface with respect to some areas where there was not a consensus among those folks that did testify to us on issues. So, it was a little bit more difficult. For example, how deep do we go in terms of our recommendations and maybe you could step us through those things because those are going to be -- that is going to be a major struggle for us during this next two hours in trying to figure out how deep do we go with these recommendations.
MS. AMATAYARUL: Yes. And I would just echo Simon's comment. Obviously, I tried to be as honest about going through the testimony as I possibly could to try to cull out, you know, what everybody said, but there was obviously some filtering because I did try to look at, you know, is there a recommendation that only one person mentioned and it doesn't fit the scope or it doesn't have an issue associated with it or something like that.
Unless it was mentioned several times or it was brought up by the committee members, you know, I tried to incorporate it into something else. So, there is a little bit of filtering, but I think it is now at the stage where you need to filter to a much more extensive level and really need to get out exactly what you want.
I think what Jeff was referring to was that I did pick up throughout the course of all the testimony two issues primarily that I think you really need to wrestle with and they are not just issues that relate to any one specific recommendation but the kind of set of recommendations at large.
The first one is that there was definitely mixed testimony as to whether or not specific standards should be mandated. So, there were some people who basically said just tell us what standard to use and we will use it. I want HL7 for this or I want whatever for that.
Then there were other people who were -- we want the standards to evolve in the marketplace and it is totally inappropriate to specify a standard. So, I think that is an issue that you folks are really going to have to grapple with.
The other issue was that --
DR. YASNOFF: Can we stop there and talk about that issue, please?
MS. AMATAYARUL: Yes.
DR. YASNOFF: This is Bill Yasnoff.
You know, I know I missed one or two meetings, but that is not the testimony that I heard. Maybe I misunderstand this. Certainly, there were virtually no testifiers who said we want you to adopt the standard, this particular standard. But my hearing of the testimony was that there was an almost complete consensus that the government needed to do something in terms of getting standards adopted and the only testimony that I recall that specifically said the government should not do anything was the American Medical Association that said it should remain in the private sector.
There wasn't, to my recollection, which may, of course, be totally wrong, a single other testifier, who said the government does not have a role in facilitating this, making this happen, not necessarily mandating specific standards, but making sure that that standards occur so this -- either I misunderstand this or I -- this is not clicking in terms of my hearing of the testimony.
MR. BLAIR: Did you want to go next or --
MR. MAYES: I don't really quite like that, though, because I think there was testimony that did say the government should adopt a particular standard, not this particular standard, but a particular standard, ala HIPAA.
DR. YASNOFF: Some standard.
MR. MAYES: Some single standard, ala HIPAA.
DR. YASNOFF: That is what I am saying.
MR. MAYES: There were others and I think it was more than just AMA, who didn't want to go quite that far. Some testimony was explicitly to the other extreme saying "no, no," you know, it is -- other than give us some money to help us have conferences go, I think there was a sense from some that, you know, let's wait and see what happens with the HIPAA standards, with that approach, as exemplified by the HIPAA transaction and other standards before we jump over that particular cliff and commit ourselves to that being the way the government ought to handle this.
MR. BLAIR: Let me put this in the queue. I think Michael is next and then Simon is next and then let me insert myself after that.
Michael.
DR. FITZMAURICE: I just wanted to raise a technical point. I did hear one other testifier say that she didn't see that the -- a role for the government. The government should stay out of it. That was, I think, the representative of the American Association of -- it was Jane Orient(?).
MS. AMATAYARUL: Physicians and Surgeons.
DR. FITZMAURICE: Physicians and Surgeons. I was going to say something -- American Association of Physicians and Surgeons. And I think the sense of it was that they didn't see the benefit and they wanted that information to be kept private.
With regard to the American Medical Association, they wanted to see a private sector solution. I don't know whether they would want the government to support the private sector solution or to have no government support of a private sector solution. I don't remember that as part of the testimony, that they thought it should be vested in the private sector is my interpretation of that.
DR. COHN: I guess I should make a comment. I am actually not sure -- but beyond that I am not sure that I hear any inconsistency between what Margaret was saying and what Dr. Yasnoff was commenting on in the sense that Margaret was talking about specific standards ala this specific standard will be implemented now.
Bill is saying that he heard a lot of people saying that they want standards.
DR. YASNOFF: Some standards.
DR. COHN: Well, I think a lot of people said they wanted standards and then Dr. Fitzmaurice is commenting, well, gee, he heard some people who said they didn't want any standards.
DR. FITZMAURICE: Right.
DR. COHN: So, there are some, a lot. There is a question of what level. There are many ways to skin the cat of standards and promoting standards, one of which is identification of specific standards. There are many other ways to do it, to get to the same end. So, just once again, I think it informs us. Once again, I am just sort of hearing all of this and don't think there is anything in conflict so far that I have heard.
Jeff.
MR. BLAIR: I feel like I am, you know, I am this roll of -- you know, what do we remember. This is my recollection of the tapestry, the landscape. Okay? I have to divide it up into message -- folks that testified on message format standards versus those on terminologies and then within those two groups, whether they were developers of these standards or terminologies versus users. Okay?
Given those four segments, here is what I can recall. Among the message format developers, I think that they felt as if they were not asking for us to identify or adopt a particular standard because they felt that the private sector was doing just fine.
Among the users, I think that what I heard -- the users being primarily the vendors that testified to us relative to message format standards, I thought the users were saying it would help them if we recommended that certain message format standards be adopted, but even more important than that, that we participate or facilitate the coordination. Okay? But those were recommendations that I thought I heard from the user sector, but it wasn't that intense.
It was that would be desirable, in the category of it would be desirable if we remember adoption of message format standards by name. On the terminology area, what I can recall is that we had over 30 testifiers, who developed medical terminologies and I do not -- there was only one that I recall that stood up and said I want you to fund my development. Kind of stood out. And all of the other developers, again, did not want to encourage us to state that the Department of Health and Human Services should adopt.
However, on the users, especially the users that had been most advanced in terms of developing clinical information systems and electronic health records, those folks seemed to be very explicit, very strong, in saying that it would be very helpful if our committee specified which terminologies they should focus on. They already -- as a matter of fact, it was interesting because they even gave us a list and I selected those that I thought were especially useful and I asked Jackie to make copies, which we will be getting a little bit later, and I picked out 3M in the acute care center, medicalogic in the ambulatory sector and Jeff Rose's testimony because those three, I think, had made more progress in pressing the issues and finding the problems more than anyone else.
I thought, you know, that might be helpful for us to go back and see what their recommendations are as we go through these pieces, just as a complement, just as a background. So, anyway, those were what I recall and that is not to say that there was not a diversity.
MR. MAYES: Jeff, maybe I can recast this. I mean, you know, what you are stating is the obvious, which is the developers of certain ones are afraid theirs won't be the one that is picked. So, they are, of course, much less inclined that the government should name a particular standard; whereas, the users don't really care because they have a vested interest.
I think perhaps what we need to say, what this really reflects is one of the underlying problems, which is that there is an underlying business in standards and it is, of course, much more strongly reflected in terminologies because many of those are proprietary in nature. They are not being developed in a completely open public SDO type structure. So, they represent to varying degrees a certain revenue stream for things. I wouldn't put all this in there, but I think that it is important to recast -- you know, I think it is important to recognize there was a difference in opinion as to how specific or non-specific the government should be, but it tended to break down along class lines, at least along lines of those areas that are being driven standards and those groups that are driven by the need to use some kind of standard.
Other comments?
DR. COHN: Bill Yasnoff and then Margaret.
MR. BLAIR: Bill Yasnoff, then Margaret and then Richard Ferrans.
DR. YASNOFF: Jeff, I certainly don't disagree with your summary of the testimony and I realized as people are talking that in my summary of the testimony, I automatically discounted everybody with a conflict of interest. So, any -- you know, I don't care what the College of American Pathologists says about standards or any other standards developer or anybody who is in the business of standards.
The testimony that I was particularly keen on are the people who are trying to use the standards and those people almost all, if not all, said we want the government to designate some standard. Now, people didn't come here and say, well, I want SNOMED and I want HL7 and so on. They didn't do our work for us, unfortunately.
But the folks --
MR. BLAIR: They came close.
DR. YASNOFF: The folks who do not have conflicts, in my view, uniformly said we need the government to set standards and that will facilitate further progress in this area.
MR. BLAIR: Simon.
DR. COHN: Actually, Margaret A. --
MS. AMATAYARUL: I just wanted to follow up on -- we really only talked about the first bullet point with respect to adoption and certainly I looked at all the testifiers' comments, whether they were from a supplier or vendor of standards or not.
But there were some message format developers, who specifically referenced that they thought, for instance, the HL7 RIM(?) ought to be adopted as a standard.
But the second point was that a lot of the testifiers apparently came to the testimony with the perception that others who would testify before or after them would want standards to be funded by the government and there wasn't -- there was not really anyone who specifically said we want standards development to be funded by the government, such as in Europe.
But there certainly was, you know, consensus, it seemed to me, or at least a large majority of people feeling that they definitely felt that the role of government was in some way, shape or form to promote standards and offered a lot of different ways to go about doing that, including, you know, serving as example or funding some of the standards development processes in part, not totally, but subsidizing in some small measure.
MS. FYFFE: They wanted the government to do something.
MS. AMATAYARUL: Something.
PARTICIPANT: Something good.
MS. FYFFE: Yes, to facilitate national standards.
MR. BLAIR: Richard Ferrans.
DR. FERRANS: And I agree. Certainly, my read on the testimony was that people did want the government to do something. When you take the people who had conflicts, I think, I think it was uniform. Everyone said please send money and I do think that people made a good business case as to why that was necessary. I should add that also. But I do agree that the government's role in funding that was fairly unanimous.
With respect to people's views on picking specific standards, I was thinking the same lines as Jeff of separating it out with message format and terminologies. I think with the message format, I think the message was a lot clearer in terms of people being more specific, rather than in the terminologies, wherein the education process, I think, there was agreement that we weren't quite there yet, at a very high level.
I also agree that the fact that people didn't come out and say, you know, you should do HL7 or X or Y or Z, I think in many cases the flavor of a lot of the testimony was educational in nature and I think people for reasons that Bob said and other reasons weren't going to come out very strong and say pick X, Y, Z and the fact that they didn't, I don't think we should infer that they don't have a preference in that area.
I think a lot of the people are known and we sort of know where a number of people stand on that subject.
DR. COHN: I actually was just going to try to sum up for just a second, though maybe I should let Kathleen talk and then I will go after her.
MS. FYFFE: I don't mean to interrupt the thought process here, but suddenly I became kind of fearful of something in terms of our report. We are also supposed to provide legislative proposals for such standards. Are we doing that?
DR. COHN: It depends on what our recommendations are.
MR. BLAIR: In other words within the scope of our recommendations, it could be -- it might include legislative proposals, if that is appropriate.
MS. FYFFE: Okay.
All right. I am going to get ahead of everybody now. Okay? What I am going to suggest is we have -- if we have to come up with some sort of legislative proposals and the government needs to do something but the private sector wants to be involved, you could always suggest something like, okay, private sector, you have got three years to come up with a national standard and if you don't do it, then the government is going to name a national standard.
MR. MAYES: But who in the private sector would say, okay, we have come up with it?
DR. COHN: Yes. How would you determine that?
MS. FYFFE: There are ways to craft recommendation language for that, but if it the private sector, you really can't name too many. I mean, you have got to leave it over to the private sector.
I don't mean to get ahead of ourselves here, but --
MR. BLAIR: Could I simply suggest that, Margaret, could you capture that as one of the alternative recommendations that is available to us for any of these things?
MS. FYFFE: That strikes a balance in terms of private sector concerns, as well as the government must do something.
DR. COHN: Yes, I actually wanted to just try to summarize a little bit of what I am hearing and maybe make a comment to allow us to move forward here.
First of all, what I have heard is that the people heard the two comments that Margaret made about uncertainties and there was also a fairly reasonable discussion about the fact that some of those concerns are role based. We can decide later on if we want to do a further analysis about that, but certainly that is the case.
Now, I personally find that the two comments are of such high level -- and I think we kept commenting on that, well, gee, in this area it goes down to this level and this other issue area, it goes down to this level. Whereas, is it useful for us to understand, it is really going to be as we begin to look at the issue areas that we need to reflect more on the summary comments you made.
So, I guess my own thought is is that we need to somehow reference that role-based issue just to be aware of that, but that really this conversation takes on a little more life when we move from the 30,000 foot level down to the 10,000 or the 5,000 foot level, depending on what we are seeing and seeing where we come to.
Now, I was -- I know Dr. Yasnoff, I think, has a comment. I saw him raise his hand. I actually afterwards have a question to, hopefully, begin to move us -- really a question about guiding principles. I don't know if it is time right now to ask that or we should let Dr. Yasnoff --
MR. BLAIR: Could I save that -- well, actually, okay. Dr. Yasnoff, go ahead.
DR. YASNOFF: I wanted to go back, Simon, to, I think, the point you made at the beginning, which I agree with, which is that the -- what we have in this document so far is a jumping off point. There aren't very -- the recommendations here as they stand are very non-specific and almost -- they are just very much -- they are research, not even guiding principles. So, I would like to see us be much more specific in our recommendations.
Because of that, I am concerned about this point in reading this. If I hadn't heard the testimony, this point about adopting standards, to me, is not a -- I think if that is the testimony, then that puts us in an awkward position in terms of making the kind of recommendations I think we want to make. In other words, there was among the -- again, I will try to be more specific -- among the non -- the folks who did not have a conflict, there was an almost unanimous desire for the government to do something in this area and that is not reflected in these points. I think that that unanimous desire is going to be reflected in our recommendations. So, we are creating a potential inconsistency.
MR. BLAIR: You are right on target. And as Margaret began to pull together, you know, all of these items and since we hadn't had the opportunity to meet as a group, the document, in fact, was intended to facilitate discussion.
One of the pieces -- and I think that is why you see guiding principles here and why we also have a copy of the guiding principles that Michael Fitzmaurice had pulled together. He modified the ones that were used as a guide for the financial administrative transactions -- is that if we are to "do something," as you said, the testimony -- especially users who were winding up, said we need to do something and some of them were very explicit about tell us which ones you want to adopt.
The first step for us to do that in some kind of a coherent manner would be for us to at least agree on the guiding principles and when you get to medical terminologies on the criterias and attributes of terminologies. And, so, I think Margaret has in the way she has pulled together the document will help us to at least agree on those things. If we agree on those guiding principles and on the characteristics and attributes of terminologies, then that would put us in a position to take that next step to say what should be done in each area.
DR. COHN: Okay. And actually I guess just beginning to answer some of my question and maybe Mike wants to jump in also because I saw that many of these recommendations were guiding principles and for the life of me, I mean, I am expecting actionable -- now, maybe -- I don't know whether there are always going to specific standards, but I am expecting actionable recommendations.
For the life of me, guiding principles aren't actionable recommendations. They are the things which you develop action about, I think. Though sometimes I am not even sure about that. Maybe Mike can comment on that because he has been really involved with developing guiding principles.
DR. FITZMAURICE: Simon, I think you are right on that the guiding principles are -- when you are in a conflict between one thing or another, you go back to your guiding principles. When you are making a recommendation, you say does this violate any of the other recommendations? Does it violate our guiding principles, given that we have agreed that these are the guiding principles that want to guide us?
Our recommendations should be as specific as we can make them within the scope of our professional judgment and the information that we have gathered. So, you are right on target to say we need some actionable items because the people who are going to be looking at this, the Secretary, Congress and the public, will want to know what to expect if the recommendations are followed.
They should see some changes and then they should be able to refer back to the guiding principles and say, yes, this follows the guiding principles and it benefits us. It helps us in a business sense. It helps us in a quality sense. It helps us in an access sense.
DR. FERRANS: Jeff, this is Richard.
There was one other point that I wanted to make about some of the testimony --
MR. BLAIR: Are you here or here?
DR. FERRANS: The point I wanted to make was -- and specifically with reference to the American Medical Association, Kathleen mentioned earlier about who is our audience and, you know, they certainly did stick out some in terms of their opposition to regulation. I think if there is not an appropriate explanation of their role as a standards developer organization, I think any mid-level staffer on the Hill is going to go, well, the AMA opposes this, what are these guys doing? I think it is
-- in the interest of fairness and disclosure, I think we need to address that appropriately because it is not common knowledge out there and it ought to be for the purpose of this report.
MR. BLAIR: Bob has a comment and Kepa has a comment and then after those two, I would like Margaret to go ahead and begin to take us through.
MR. MAYES: Brief comment.
The audience of this report is, first, the Secretary of the Department of Health and Human Services. The charge is to make recommendations to the Secretary. That is the explicit audience.
The second explicit audience is, if appropriate, legislative proposals to Congress. Obviously, these are public documents and they are general things. So, you want to remember that.
These are not regulatory -- I mean, you know, the type of discussion that you might want to get into, there is no need, as made the point earlier, I think, at the very beginning by Simon, we could ignore or you, the committee, could frankly ignore everything you have heard. You do not -- this is not like public comment to a regulation.
There is no requirement for the committee to go through and, one, summarize all comments and comment as to why they did or did not take these. This is testimony in hearing, all of which is public. You may want to make a note in the report that verbatim transcripts can be seen for all public, but it is the responsibility of the committee to make recommendations, not to adjudicate between conflicting testimony. There is no requirement that the committee actually respond point to point to every bit of testimony and sort of say we think this was right or wrong.
MR. ZUBELDIA: My comment was going to be along the same lines to what Bob has said. I think that the people testifying before the committee did not have a clear understanding of what is the charge of the committee and I think that specifically the concept of adopting standards or recommending standard production can have at least three different meanings. It can have the meaning that the committee could name a standard for voluntary implementation. That is very weak, but it could be that we just name a standard production.
A little bit stronger would be that the government itself in its hospitals, in its own health care system, adopts a standard that -- mechanism for funding also, but it is the government adopting a standard, not everybody else, but the government doing it.
And even a stronger one would be in line with what HIPAA has done for transactions is that the providers have required to adopt a standard. I think that in that sense, for instance, the AMA is probably opposing this because they probably see that if the committee recommends the adoption of a standard, it could become mandated. If it is mandated for all the physicians in the country to adopt an electronic medical record, that will be very expensive.
So, I think we need to have it clear as to what will be the implications of the committee's recommendations.
MR. BLAIR: Michael, do you have --
DR. FITZMAURICE: I wanted to revisit the point that the recommendation should be as specific as possible. Where we think it is appropriate, we should also specify who should undertake the action, i.e., what federal agency or what component of a federal agency or what component of the private sector should be assisted or supported if that is appropriate in our recommendation.
MR. BLAIR: No other hands up. Okay.
Could I see if I could summarize what I have heard so far to see if we have a platform for Margaret to continue? I really want to make sure that there is a consensus as we are about to step forward because I think what I have been hearing is that -- is that the testimony at large and I think the sentiment on the committee as well is that we be specific and that we respond probably more to the users than the developers, we consider, you know, the users -- excuse me -- the developers as well, but that we especially respond to the testimony of users, which tended to wind up for the most part saying that we should be more proactive and more specific.
I think, and tell me whether I am right, as a foundation on this, because otherwise we may wind up changing -- we may need to change the way we proceed, I think that Margaret was very cognizant of this as she pulled these things together, but that there was enough diversity -- there was a lack of consensus, at least in the testimony, which was her role to be able to pull this together, that it was difficult for her to wind up getting as explicit as she wanted to and that as an interim step to try to build consensus within our committee in the process of coming down with more explicit recommendations, would be in those cases to wind up at least agreeing what our guiding principles should be to get to those more explicit decisions. Is this correct?
DR. COHN: Are you asking the committee or are you asking Margaret?
MR. BLAIR: I am asking the work group whether you agree with this as a process.
DR. COHN: Well, I guess my own comment is that I think it depends on the issue and I think where we can get more specific first time around, we should try to get more specific first time around.
Many of the guiding principles are actually already listed as our guiding principles from a previous attached document that we sent to the Secretary. So, some of those can be dispensed very quickly, I would imagine.
So, I just don't think our focus is on -- guiding principles are fine, but 30,000 foot is always easiest. Now, Kathleen Fyffe has a comment.
MR. BLAIR: Okay. Kathleen.
MS. FYFFE: Let's go back to what our role as a committee is and that we are here at this particular point in time and any time that we have these meetings as a federal advisory committee to the Secretary.
Are we ultimately more concerned or should we ultimately be more concerned about the good of the patient in all of this and what the computer-based patient record system is going to do for individual people in this country than different interest groups? I mean, this is a pretty elementary question, but we might want to keep that in mind.
MR. BLAIR: Okay. Bob Mayes just commented to me that he thinks at this point that if we allow Margaret to proceed that it will sort out whether or not we need guiding principles on a particular area or whether or not we could go to more specific action, which I think is also, Simon, what you were indicating.
So, Margaret, please proceed.
MS. AMATAYARUL: So, you want me to lead each issue and recommendation, Jeff, or what do you want me to do here to help you?
MR. BLAIR: I think that would be helpful so that we could focus on those for the message -- yes.
MR. MAYES: I have a comment just on the title of that section.
I really -- and before you can get into any of the individual issues, I think that message format standards is somewhat too narrow for the issues you are going to need for this. It is actually message format/content standards. I think that that is supported both by the way the HIPAA regs were written and I also think that if we look at any of the large format standard SDOs, such as X12 or HL7, they are all moving to focusing more and more on standardizing the content of the messages and less and less on particularly maintaining a particular wrapper standard because the realization is technically the wrapper is becoming less of an issue than what is the inside message.
MR. BLAIR: Bob, how does this overlap then with medical terminologies?
MR. MAYES: Well, I don't think -- I think terminology is used to describe content, but it is not the content, just as message formats are used to transmit the content but it is not the content. It is my opinion that when we talk about information sharing, those are simply the tools that we use to define the information, if you will, or to talk about the information, but they are not the information itself.
So, somewhere in here I would like to see "content." I could use semantics, but I think "content" is probably a more accessible term.
DR. COHN: Can I make a comment because actually I agree with you and I thought that this -- especially as I look at some of the recommendations that seem too limiting. In some ways to me the real issue here, though, is interoperability. Now, of course, interoperability means everything and probably all of our recommendations fit under "Interoperability." But that is really the key concept we need to be cognizant of in this particular area. If it begins -- and we may need to readjust the title as we go along, based on that sort of concept, which I think, to me, is the salient issue here.
MR. MAYES: Jeff, the only reason I really sort of bring this up is that I think that this is being recognized by the SDOs themselves. I mean, they are all moving towards sort of these object-oriented type of approaches, whether the HL7 RAM --
PARTICIPANT: And information models.
MR. MAYES: And information models. Those actually --
MR. BLAIR: Is there anybody in the work group that objects to that modification, to adding -- to saying that this section is message formats and content?
DR. FITZMAURICE: Jeff, this is Mike.
I think that Simon and Bob are both right. Content is king now and technology is changing. There is a shift to Internet protocols, for example, in document formats. I would like to see us go through the recommendations and then visit how we might want to label this section or how we might want to break it out.
MR. BLAIR: Let's do that. That is fine. Let's do it.
Margaret.
MS. AMATAYARUL: Okay. The first issue was while most testifiers agreed that considerable progress has been made to achieve interoperability in patient medical record information systems through message format standards, it was also felt that these standards have not achieved true plug and play capability yet. Users are compensating for the lack of plug and play capability by employing bilateral agreements to make message format standards work.
The recommendations on -- that were proposed to match this particular issue are three. First, the government should adopt guiding principles for PMRI message format standards that include the principle of complete interoperability so that bilateral agreements will not be necessary.
Second, that implementation guidelines to assist in the use of message format standards in medical terminologies will be needed. We had a question what should the role of government. That is actually why I asked the earlier question.
Then an issue that we associated with -- I am sorry -- a recommendation that we associated with Issue No. 2 also pertains -- and you will see throughout this that you can't develop recommendations specific to an issue without overlap in issues and recommendations. So, there are some, you know, cross reference there.
DR. COHN: Actually, I did want to make a comment here.
I actually fundamentally agree with the way 1 looks. I actually think, however, that 2 is actually a part of 1 and that there is a recommendation around frameworks, architectures and models that really is just in further amplification of the interoperability discussion.
MR. MAYES: Simon, I agree and I think that is why Margaret connected the recommendations to 2. I think, though, that one narrow focus of what she is saying in 1 is really a conformance issue and that -- I mean, if you look at it strictly from the message format thing, the problem is we have these standards, but we don't have really good mechanisms for determining conformance to the standards, except for these bilateral agreements where we a priori agree on a specific form --
[Multiple discussions.]
MR. BLAIR: -- so, that is -- was identified as a separate issue because that --
DR. COHN: I actually had agreed with Bob when I was making notes. I saw conformance in 30 something or whatever and thought that it actually should be up here also.
MR. BLAIR: So, you pull that up here?
DR. COHN: Well, I think that is part of implementation guides, I think.
MR. MAYES: Yes. I think if you look at what the recommendation -- you know, if you wanted to more narrowly -- I think in the broader sense, Simon is right in that No. 2 really is the broader -- No. 1 sort of falls underneath there and it is somewhat narrower. The way it is described vis-a-vis the recommendations, I see it as a conformance issue and would bring under the conformance --
MR. BLAIR: Could I suggest this because -- and we don't have to do it this way, but to be honest with you, I really felt as if it was helpful to try to separate out each of these issues because I thought that when we start to review this, that first issue on the adoption, that that would have certain discussions and pieces to it and the issues of conformance and implementation guides, that becomes moot if we are not adopting anything.
So, if -- you know, maybe you are already to the point where -- could we take them sort of one at a time because if there was general agreement on adopting, then I think there needs to also be a discussion as to what our criteria should be as to which ones we select.
MR. MAYES: That is not what this issue says, Jeff. It doesn't talk about adoption.
MR. BLAIR: Doesn't the first one wind up saying -- the recommendation -- did I not hear Margaret correctly?
DR. FITZMAURICE: It says adopt the guiding principles.
MR. BLAIR: Ahhh. Thank you. I didn't hear it correctly.
MR. ZUBELDIA: I would like to -- I don't think the government should be adopting guiding principles. I think the government should be adopting message format standards. The government should be adopting these things. I think probably NCHS should be adopting guiding principles to recommend which standards to adopt, but the government should be adopting the standards themselves, not just the guiding principles.
MR. BLAIR: Is there a general consensus on that point? I think that gets right to one of the issues here, that we could -- do we all agree on Kepa's modification to that first recommendation?
MS. FYFFE: Kathleen Fyffe. I agree.
DR. COHN: Yes.
MR. BLAIR: Yes?
DR. COHN: Well, I think we are all sort of saying that the guiding principles are stuff that we use to decide what standards there ought to be. I guess that is what you are saying, Kepa.
MR. ZUBELDIA: I think NCVHS adopts guiding principles for our use --
MR. BLAIR: Very good.
MR. ZUBELDIA: -- in recommending the standards to be adopted by the government.
PARTICIPANT: I was going to say the government also used guiding principles, as I understand it, when they did NPRMs. So, it is helpful --
DR. FERRANS: Certainly the view of the GCPR has been also that the government should do what it recommends. Absolutely.
MR. BLAIR: Okay. Margaret, you have captured that modification?
MS. AMATAYARUL: Yes. I have made a note to do so.
MR. ZUBELDIA: Along that same recommendation in that sentence of A that says message format -- and the government should adopt PMRI message format standards that instead of include the principle of completing interoperability, that enable completing interoperability. I think that is an absolute criterion. It can't just include the principle of interoperability. You have to make it work.
DR. YASNOFF: I have a question.
When we are saying "adopt," we mean -- do we mean adopt for its own use, as opposed to -- as, Kepa, you pointed out before, the government, unlike other health care plans can require everyone to do something. So, I just want to be sure we are clear as to what we are saying. So, by "adopt," do we mean use itself within its own health care programs, et cetera, or do we mean impose universally?
DR. COHN: Can I make a comment? Because I actually think we have three options. One is to adopt in government programs, which is certainly one option I think others have mentioned.
The second one is along the HIPAA style recommendations, at least my reading of the HIPAA regulations provides the Secretary some latitude for the development and -- not development, but identification of other standards that help with administrative simplification.
So, that sort of standard would be where a provider is doing something electronically and transmitting that information. That is the language of the HIPAA administrative simplification standard, which is to say that someone who is maintaining the paper-based environment or not transmitting things electronically would not be required to meet that standard.
Then, of course, the third, which would require probably require new legislation, would be saying that everybody needs to implement systems that have X, Y and Z functionality implementing A, B and C standards, which is probably not where we were likely to go. Probably the middle one may be what we want to think about.
MR. MAYES: Actually, I wanted to follow-up on that, Simon, because I would make a recommendation to us following the discussion earlier about being specific. It might be quite fruitful. I think you are going to find in everyone of these issues that you could adopt -- you could adopt any of those three approaches and what I would suggest is that it may be quite fruitful to pick two of them. In other words, to make a specific recommendation -- because it is a lot easier for the government to decide it is going to use something in its programs than it is to -- as we have seen with HIPAA than it is to go the broader and say everyone is going to use it.
There is no reason why you can't say, you know, both should have it. The Federal Government should adopt this and we think that this is good enough so that legislation should be proposed because the Secretary -- and that is the difference. One Congress does; the other the Administration does.
DR. COHN: Well, I actually -- at least my reading of HIPAA gives the Secretary latitude without legislation.
MR. MAYES: Well, only within the context of the initial legislation and let's say even legislation, the Department of Defense or the Veterans Administration can decide these HL7 without doing any regulation.
DR. COHN: Oh, no, I agree. I think the --
[Multiple discussions.]
MR. MAYES: -- through this whole list of issues, it would be, I think, fruitful to have a range of suggestions, those that are perhaps not as broad of impact, but are more easily implemented first and as well as those more broadly, particularly since some of these the issue is, well, let's let somebody try it out first. You know, it is too expensive for me as a single provider in the private sector, but, boy, you know, if the Federal Government was willing to spend some of their money to try it out, I could see whether or not this is something good or bad.
I mean, we play that role oftentimes.
MR. BLAIR: Go ahead, Simon.
DR. COHN: I am nodding my head actually and the only comment that I am making is that my understanding of the legislation is is that middle ground, which is a HIPAA-style --
MR. BLAIR: Could you rephrase exactly because I think it is important for the work group to lock in on that middle ground piece because if that is -- that might be the easiest for us to move forward with. That might have the broadest consensus and if we adopt -- if we sort of have that in our mind now as we hit the rest of these recommendations, we will see if they all fit to that.
DR. COHN: Well, you may or may not agree with the middle route because the first one that I propose in terms of implementation issues was as Dr. Yasnoff mentioned, being adopted by the government for its use internally.
The second one was development or expansion, recommendations that the Secretary use her regulatory discretion to expand in places where providers are transmitting, et cetera, et cetera, information, but would not require providers to actually buy new systems and implement things that they don't have things or don't choose to have things.
The third place, which is a very extreme proposal, I would not suggest to you, but we just need to be aware of it is is that the government could say, you need to have these systems and you need to implement these standards in these systems and we just need to be aware of that and that may be appropriate some places --
MR. BLAIR: And that is more like a mandate.
DR. COHN: That is truly a mandate. That requires legislation.
MR. BLAIR: So, does the group overall feel like at least at this point if we try to keep the middle proposal in mind and test it as we go through the rest of these pieces, where when we talk about adoption, that we are talking about adoption for use within the Department of Health and Human Services and the private sector organizations that interface and send health care information to the Department of Health and Human Services, but it stops short, explicitly stops short, of requiring anybody to move to electronic systems. In short, it is consistent with the way that the regulations worked on the first piece of the Administrative Simplification Act. Did I paraphrase it correctly?
DR. FERRANS: I am confused.
MR. BLAIR: Okay. Richard.
DR. FERRANS: I guess when I hear -- when we talk about use in government programs, I want to break that into use within government agencies that are providing health care versus, you know, this is not mandatory, except if you want to bill Medicare, which is an entirely different issue.
If there is a -- I have a question of overlap, which one we are talking about at any given point. So, I just wanted to clarify that one issue. And No. 2, I would just like to hear some more discussion about the Secretary's discretion.
When I hear Jeff saying the middle proposal, I think he is referring to use in the government, but I thought the middle one was what we were talking about with regard to the Secretary.
MR. MAYES: Bob thinks that he can clarify that.
MR. MAYES: I would suggest that we actually are looking at -- let's phrase it a little differently. There are proposals that can be adopted by the government without regulation. There are proposals that can be adopted by the government that require regulation and then there are proposals that cannot be adopted by the government without legislation.
That is sort of how I would characterize it and I think that it would be fruitful for us to -- we might want to say, well, it is the middle ground that we are most interested in, but where we see opportunities on either of the ends --
MR. BLAIR: Very good.
MR. MAYES: -- that we not shy away from making those because, one, you are supposed to make legislative proposals if appropriate. So, that is the sort of one end and, let's face it, if it can be done by simply an administrator, you know, whether it is an agency, a department or the President simply saying we are going to do it this way in the government, it is easier.
MR. BLAIR: That might be a way of characterizing it.
DR. COHN: Kathleen has a comment.
MR. BLAIR: Kathleen, yes.
MS. FYFFE: We haven't taken a vote yet. Right? We have a -- okay.
In the best interest of patients in this country, regardless of whether they are in the VA, DOD, Indian Health Care Service, private sector, I think that we should recommend that the government legislate national standard or national standards for computer-based patient records, et cetera.
MR. BLAIR: Let Congress pass legislation?
MS. FYFFE: Well, that is a different issue.
MR. BLAIR: You used the word "legislate."
DR. YASNOFF: Legislate is not a different issue. Congress is the only --
MS. FYFFE: No, no, no, no, no. We can recommend.
MR. MAYES: We can recommend legislation by Congress.
MS. FYFFE: That is correct.
DR. COHN: But we can also recommend regulations.
MS. FYFFE: Correct. Well --
MR. MAYES: Or simply use.
MS. FYFFE: Then let me clarify what I have said.
The agencies, if it is within their power to require without regulation, they should do it. If it requires regulation, do it. If it requires legislation, do it. Okay? All the way across.
MR. MAYES: But the way that you would implement that same recommendation in those three levels, we could get specific enough so that -- you know, it might be somewhat slightly different because of time frames and other issues.
MS. FYFFE: Well, now, I -- details, details, but that is my -- that is what I am throwing out as a --
MR. BLAIR: Kathleen, could I suggest that until we get down to the specific situations, as we go through all of the stuff that Margaret has pulled together, I think there may be some of those where legislation is going to be the best answer, but there are many of them, which will fall into either Category 1 that Simon articulated or Category 2 that Simon articulated.
I think Simon's framework was extremely helpful because I think that as we go through each of these specific things, we will wind up seeing what is the appropriate recommendation that would fit.
Michael has a comment.
DR. FITZMAURICE: I just want to interject that if we think something is good, it should be good for all the patients and all the providers, not just good for Department of Defense and good for VA. So, I would let recommendations about which specific government agencies should adopt the standards we think are good everybody, to be a secondary matter of implementation or of timing or of structure, but to focus more on what is good for all patients and what is good for all users.
MS. FYFFE: Let me clarify one thing. We have to have a standard that everyone uses regardless of where they are in terms of being Indian Health Service, DOD, VA, private sector, whatever.
So, I am not in any way suggesting that we have the current fragmentation of standards that might exist in different pockets around the country.
MR. MAYES: I agree with you, Mike, but I would also like to point to the current example of errors in medicine, in which we see a report that is hopefully ultimately going to drive some legislation, but we had the President basically say, guess what, all the federal agencies because they can act tomorrow have 60 days to begin to put in place something.
So, you are not saying that it is only good for people involved in the federal health care system. I am simply saying some recommendations might be worthwhile saying while we get this legislation or while we get the regulation, we should have the government go ahead and do this because it can be at least implemented in some sector more quickly than overall.
DR. COHN: I was actually just going to comment, I think we need to get down to the specifics here and look because I could imagine, for example, that there may be areas that are not mature enough for final standards, where they might say, gee, the government ought to do this and then if it works, it ought to become a standard.
That may be an -- that is one of our tools.
DR. FERRANS: I really agree with what Kathleen said. It would be nice if we sort of came out and said putting everything together, we overwhelmingly agree that this needs to move forward and, you know, in areas where it is mature, we ought to do -- you know, it is our goal to see standards adopted uniformly and in areas where it is not quite there, we certainly want to find a way to accelerate the process exactly.
But coming out and saying that in the beginning and just sort of saying that and saying -- and then the rest sort of becomes a road map of how do we get there and the specifics of, you know, what is the appropriate, you know, methodology, whether it is, you know, government agency adoption versus expansion of the Secretary's use versus some of the other recommendations, I mean, how does that sound as -- because then it is a sort of declarative report. Here is the background. Here is -- we took testimony from a year, you know, at a very high level. Here is what we distilled and then here is how we get there.
That might be one approach. I don't know.
MR. ZUBELDIA: I have a comment. The report of 1993 recommended that the industry voluntarily adopt ADI(?) standards and that if the industry did not adopt voluntary ADI standards, that the government regulates the adoption of ADI standards. From what I am hearing Kathleen say, I think she is looking for something like that, but in reverse, maybe have the government come out with regulation that will have a voluntary implementation time frame of maybe five to seven years or whatever.
During that time frame the providers can adopt it if they want to adopt it, ala HIPAA, and the government will adopt it immediately and if there is no voluntary adoption of that regulation then come up with legislation that would mandate it. Is that what I am hearing you say?
MS. FYFFE: Is that what I said? I think that is what I said earlier, at least in theory. Let me try and repeat what I said earlier.
In order to have the private sector involved in the development of the standards, it might make sense to have a time frame and a due date whereby the Secretary says, okay, private sector, develop a national standard in various areas and if you don't get it done within a certain length of time, then we will legislate it or mandate it. Is that what you were saying, Kepa?
MR. ZUBELDIA: I was thinking, develop a standard in some time frame. Then we will have regulation that requires that standard if you are going to implement it. At the same time, the government will adopt it for its own use and then if the voluntary implementation does not happen within a reasonable time frame, then there could be a mandated implementation.
MS. FYFFE: Okay. Here is my concern with that. If we say that in the end everyone has to use a standard in different areas, then you have to allow time for the private sector to develop a standard and then allow everyone to adopt it. Because if you say to the government agencies and so forth ahead of time go on and use some kind of standard, then at the end of the time frame when the private sector has been trying to agree on one, you have a real problem.
MR. BLAIR: I almost feel like we have the cart before the horse here. We haven't even agreed upon what our principles should be to adopt a standard and we are already thinking about, you know, the degree of regulation or legislation and I sort of feel like the cart is before the horse on this.
We had a comment by Simon and Bill Yasnoff and then maybe after that --
DR. COHN: Let Bill and Margaret go before me.
DR. YASNOFF: This is Bill Yasnoff.
I agree with you completely, Jeff. I think in order to get through what we need to get through because there is clearly a consensus that the government needs to do something with respect to standards.
But it is the details that are important and we need to get into those. And what I would suggest is that as we go through this, we identify in as much detail as we can what we would like the outcome to be. I would suggest that we not even discuss how that outcome should be attained until we get through and identify for each of the areas what we would like the outcomes to be.
Then I think we can have a very fruitful discussion about, you know, should we recommend that government agencies adopt first or should we recommend legislation or does there need to be additional study, et cetera. We are talking about mechanisms and subtleties of how we do this before we have decided what the outcomes are that we would like to see.
MS. FYFFE: So, we have to decide on what before we talk about how.
MR. BLAIR: And Margaret has a lot of those items laid out there in terms of --
DR. COHN: Yes. And I was actually just going to comment that there are actually two different streams we are talking about. I mean, one is there are actually probably some mature standards out there that don't require three years of development and da, da, da, ta, da. There is on the other hand another stream called, gee, we identify that there is a need. There isn't anything there. We, I think, all feel that we need to let the private standards development organizations working on that certain time come up to a certain level and then provide for only implementation.
So, probably we are all sort of right in all of this stuff, but it is going to be -- I mean, I think we all have this vision and I guess I would say for myself is that there is leadership provided by the government in the NCVHS and others to the public and vendors and others as to what the standards are going to be for all these systems to reduce the risk of development and to reduce the risk of implementation.
DR. YASNOFF: This is Bill Yasnoff again.
I think it is important to separate these outcomes from the mechanisms because attaining the outcomes is going to be complex because, for example -- let me give you a specific example -- if the government mandates or starts using for itself SNOMED-RT, that, in effect, creates a virtual monopoly for SNOMED in that domain and, therefore, could cause some problems in terms of escalating costs and so on.
So, we have to deal with the patient issues very carefully, but first we have to decide what the outcomes need to be and, Simon, I agree with you there are two different classes. Those are areas where standards are pretty clear and we could say this is what should be done. And there are areas where it is not so clear and there needs to be some kind of process.
MR. BLAIR: Are we at a point where Margaret can proceed.
PARTICIPANT: It is lunch time.
MR. BLAIR: Well, we are running now almost an hour behind and would it be okay with the group if we proceeded for the next 30 minutes before lunch or do we need a break now? We can proceed? Okay.
Margaret, proceed.
MS. AMATAYARUL: Where am I proceeding to?
MR. BLAIR: On the first item. You had the first recommendation, which you said the adoption of guiding principles for message format standards and Kepa had suggested that it become a stronger statement, which would be the use of guiding principles and the adoption
-- the use of guiding principles to help adopt message format standards.
Is that correct, Kepa?
MR. ZUBELDIA: I was saying the government should adopt the message format standards.
MR. BLAIR: Okay. That is fine and we understand that we would need the guiding principle criteria to figure out which ones are adoptive.
So, that modification there?
MS. AMATAYARUL: Jeff, what I have done so far is reworded this recommendation to be the NCVHS should adopt guiding principles for PMRI message format standards that enable complete interoperability so that bilateral agreements will not be necessary.
It seems like the question is should there be adoption of message format standards.
MR. BLAIR: I think that was Kepa's suggestion is that we go beyond the -- that the recommendation be more far-reaching than just saying that we would adopt the guiding principles, that we would actually adopt --
MR. ZUBELDIA: What Margaret has done here is instead of saying the government should adopt guiding principles, she changed it to the NCVHS should adopt guiding principles, which is fine, but then also the government should adopt message format standards.
MR. BLAIR: Okay. That captures your suggestion.
MR. ZUBELDIA: Yes.
MR. BLAIR: Which I think the rest of the committee pretty much agreed with.
DR. YASNOFF: This is very non-specific. Which message format standards are we going to adopt? What is the outcome that we want? To me, it is not -- we haven't gone far enough if we say here we have developed these guiding principles and our recommendation to the Secretary is use these guiding principles to adopt message format standards.
The Secretary is, I think -- if I were the Secretary, I would say, well, wait a minute. I thought this group was going to tell me what I should do. This does not tell me what I should do. Now I have to form another group to figure out, which -- what is the outcome we want? Do we want the -- let me be very direct. Do we want the government -- should the government adopt HL7?
MR. BLAIR: I agree with your point. And we do need to wind up pulling together the guiding principles that will help us select which ones are going to be adopted.
My only thought at this point is that there are a number of other things in this section that Margaret has for us to review and I think that once we have reviewed those, we will have a context and we will also have identified a number of guiding principles and criterias that will help us so that we could then wind up at the end of this, winding up saying, okay, and here is the criteria we should use or the guiding principles we should use to adopt the standards.
MR. MAYES: I actually don't quite agree with you. I think I would go back to Mike's characterizations of the guiding principles. I don't think the guiding principles help you select. I think the guiding principles help you to discriminate between potentially valid selections. When we look at our guiding principles, they don't -- it is not some sort of process, tree process, by if we start at No. 1 and they will eliminate standards as we go through.
My guess is we would have as many good standards at the end of that list as we would at the beginning. I am not sure whether they would actually give us the answer because if it was that simple, we could just give the Secretary this algorithm and say follow this algorithm and the magic answer will come.
DR. COHN: I actually have a suggestion here because I think it is -- I mean, my view is that we are going to need to go through these a couple of times. And I think that I actually agree with Jeff that we should -- I mean, I think we have identified where we want to get here and we are going to be faced very soon with the devil of the detail because just like with X12, we don't accept all X12 standards. We accept some X12 standards and the question is how much specificity can we get.
But I do think that there is value leaving this, probably moving to some of the other areas and then coming back based on -- because I think in some of the other recommendations there are actually tools that may help give us some view of how we are going to get to the issues, which I think we all want to get to.
MR. BLAIR: Bob is on my left. He is agreeing with Simon's comments. And I am agreeing with Simon's comments.
Is anyone disagreeing with Simon?
DR. YASNOFF: I am agreeing also.
MR. BLAIR: Okay. Good.
Margaret.
MS. AMATAYARUL: Okay. We also have in this section implementation guidelines to assist in the use of message format standards and medical terminologies will be needed. What is the role of government? Do you want anything further on there at the moment?
DR. COHN: Well, I think we also identified conformance testing, which is actually No. 10.
MS. AMATAYARUL: Right.
DR. COHN: Which probably becomes a part of all this, doesn't it?
MS. AMATAYARUL: Right. I have got that noted in No. 2 there.
DR. COHN: In No. 2? I said No. 10.
MR. BLAIR: I think what he is suggesting is maybe we bring the issue and recommendation of conformance testing and combine that.
MS. AMATAYARUL: Yes, I have got that.
DR. COHN: As one of the recommendations. Okay.
MS. AMATAYARUL: Under No. 2, I said this is broader than No. 1 and should include conformance testing, which is No. 10. I will move it.
DR. COHN: Well, actually I have a problem with No. 2. It is only because I don't -- even though I have written frameworks. So, I stand as actually one who has actually done this. I actually don't know what frameworks, architectures and models are and I know that no two people who talk about them define them the same way.
So, I find myself almost feeling that 2 ought to be part of something else, where it is almost like a recommendation that we need to sort of do this and -- so, I am just sort of looking at the main part of No. 2 as an issue that needs to be somehow somewhere else and it may be part of what the activities conveyed in No. 4. I also thought that B and C probably could as easily fit under No. 1 in terms of the recommendations.
MR. MAYES: A is --
DR. COHN: Well, A is -- A is already one of our guiding principles, but, yes, I mean A is already a guiding principle, which talks about technology, dependent computer platforms and transmission protocols. Is that right?
MR. MAYES: Yes, but that is, I think, somewhat different between message format. Transmission protocols are not the same as message format. You can send an HL7 message structure over many different protocols, but this gets back to the content/format. I mean, I am not sure whether a particular segment string is -- I don't know.
DR. COHN: Okay. Well, if you feel there is a difference, I am not -- it is a definitional issue that I -- but I would certainly accept A, B, C and D as really part of No. 1 and then we ought to do something with No. 2 that may involve the issue around No. 4.
MR. BLAIR: Now, if you do that as part of No. 1, the issue that they are addressing, you need to make sure the issue in No. 2 -- and I am afraid I don't have this memorized -- is also -- see, one of the things here is that -- and you will have to blame me for this, but you start to get this jumble of issues that are related
-- that are addressed by certain recommendations and none of these are mutually exclusive.
I don't know. Maybe, Margaret, could you maybe just simply make a note to explore and see if you do combine those if -- pardon?
MR. MAYES: Could actually I make a suggestion because I think otherwise we are going to wind up arguing about which level in the column. Maybe what we need to go through is sort of say, one, do we agree with the issues, regardless of where they are and then, two, do we agree with the recommendations regardless, again, of exactly whether we need to -- then we can all go back. I mean, that sorts of gives us the stuff that we don't think should be in there at all and maybe identify things that aren't in there that should.
We can always go back either off-line or whatever and argue about how many issues is this? Is this 30? Is this 50? Is this 20? And exactly which recommendations are tied to that? Because, otherwise, I am afraid we are going to get in an editing problem and we will never get through the first ten issues.
MR. BLAIR: Right.
Margaret, it is yours.
DR. YASNOFF: Jeff, this is Bill Yasnoff.
Along those lines, somewhere in here and we are not going to say where, but we are saying the government should adopt standards for PMRI content, structure, architecture and a shared information model. Government should require PMRI products it uses, should incorporate standards for content and structure.
Shouldn't we also say that the government should utilize standards in communicating PMRI information to and from other entities? In other words, any time PMRI information is sent to the government or out of the government --
MR. BLAIR: See, this is the part of, I guess, the difficulty here on how big the task is. That is an issue and recommendation that is down further in the list.
DR. YASNOFF: Oh, it is? I am sorry.
MR. BLAIR: -- for the government to use these.
DR. YASNOFF: For communications? Is that there somewhere?
MR. BLAIR: For the government to use it internally.
DR. YASNOFF: No, that is not what I am saying. We said that the government should use it internally. What I am saying is should we also recommend that when PMRI information is sent to the government or the government sends it to someone else, that it use standards. I thought that is what "adoption" meant, but that is --
DR. COHN: Yes, I guess --
DR. YASNOFF: No, it doesn't say that. It says the PMRI products it uses --
DR. COHN: No.
DR. YASNOFF: Oh, the government should adopt standards but --
DR. COHN: Well, I had a question about what that meant actually.
DR. YASNOFF: I guess I am trying to clarify that.
DR. COHN: -- regulations in place for everyone to use it or is it -- is that what the intention --
MS. AMATAYARUL: I think the intent of -- and you are referring to B?
DR. COHN: Yes.
MS. AMATAYARUL: The government should adopt standards for PMRI content and structure, architecture and a shared information model. I think the intent was that by government adoption, anybody who was sending information to it or receiving it from it would have to use that standard.
DR. COHN: So, this is a HIPAA-style --
MS. AMATAYARUL: HIPAA-style --
DR. COHN: -- regulation.
MR. MAYES: No, less than HIPAA. It requires even private entities to use it. This is more like a HCFA reg. If you want to have Medicare -- if you want to communicate with Medicare, you have to use this standard. For CDC, you have to use this.
DR. YASNOFF: Right. Can we specifically add the issue of communication so that it is clear? I guess that is all.
MR. MAYES: Because otherwise it would only refer to like GCR or internal --
DR. FERRANS: I just want to add for the record that certainly that expands it also into --
DR. COHN: Isn't that a message format standard?
DR. FERRANS: That also adds into communicating information for clinical trials. I mean, that this is really significant --
MR. BLAIR: Remedy. Okay?
DR. YASNOFF: Let me just say specifically, when you say this -- and I am now putting on my CDC hat -- you are saying that CDC should adopt standards for transmission of surveillance data.
MR. BLAIR: Right.
DR. YASNOFF: So, I just want to be sure that
-- and that is what I am intending, but I want to be sure that everyone understands that implication.
DR. COHN: Yes. Can I make a comment here? Because I am, again, a little confused. I am actually glad for you bringing up my confusion because when we start talking about transmitting things, my understanding always was that those were message format standards. If really what we are doing is suggesting that there be an expansion of message format standards to handle these variety of situations, then that is definitely a recommendation, but I think it is different than PMRI content and structure, architecture and shared information model standards, which I have sort of seen in my mind as the way you build systems internally.
I am sorry Clem McDonald isn't here for this discussion. Am I mistaken in this conceptualization?
MR. MAYES: Content certainly is beyond internal systems, content structures. That goes back to my original thing. I am a little uncomfortable with talking about message standards, format standards unless you are specifically talking about the transmission envelopes that are used.
Content starts getting in this area of core data sets or minimum data sets, that kind of thing.
MR. BLAIR: What should we do? Should we proceed with the way -- you know, I don't know where we are now. I am lost now. There are so many issues.
MS. AMATAYARUL: What I have captured is the government should require standards for PMRI content and structure, architecture and a shared information model for all communications sent to or received from the government and I think the concern is that content, structure, architecture and shared information model is not the same as a message format standard per se.
So, maybe we should propose that we add message format standard to this?
MR. MAYES: You might do that because I don't
-- I think communications means information exchange, which would, in fact, incorporate all those other things. I guess it depends on how you are --
MR. BLAIR: We are under the focus area of message format standards and content. So --
DR. COHN: Yes. You see, I guess I get confused here. This, once again, those -- these issues of what is different and what is the same and all that and one would think that the role of government in relationship to -- now, once again, I read this as having to do with how it is you develop your computer-based patient record or how you architect your systems -- but the question gets to be is is that something that we want to standardize? Are the things mature enough out there to standardize or do we want to provide government leadership in that with the idea being the people maintain their own systems in their own ways, migrate towards this new national standard.
Margaret.
MS. AMATAYARUL: I would mention also that if we really -- if here in B we are saying the government should require message format standards for all communications to and from it, that is really what we set up in No. 1 as well. I mean, we basically said in No. 1, government should adopt message format standards. Now, we are really kind of emphasizing that that is what the recommendation ought to be.
DR. YASNOFF: But adopt message format standards, again, we have this -- what does that mean?
MS. AMATAYARUL: Exactly.
DR. YASNOFF: So, what I am saying is the government should at least use message format standards for all the messages that go to and from and within -- inside the government and from the government to other folks.
DR. COHN: That is in No. 1. Right? That is recommendation No. 1.
DR. YASNOFF: I am sorry. I was reading my document instead of this --
DR. FITZMAURICE: I have got a suggestion. I have got a way of thinking about it, the message standard. I think of it in terms of there is a function that has to be done and, therefore, we need to send a message communicating information for that function. It may be ordering an x-ray. It may be ordering a drug. It may be simply communicating a diagnosis to another health care provider.
So, we have the content of the message. So, it gets into the semantics, the data elements and their definitions. Then we have within the message, how are they arrayed, in what order are they or how are they delimited so that the receiver knows what the data elements are in a context.
Then, thirdly, we have a wrapper that goes over that message that says we are going to be sending it through the telephone wire. We are going to be sending it through the Internet. We are going to be sending it through a fax machine. It is a wrapper that maintains the integrity of that message and gets it to the person, who has to perform a function on the other end.
So, I think of it more in terms of what is in the message. How do you determine what is in the message and how do you wrap it to communicate, to send it. Most important to me is the content and the definition. When we talk about message format standards, it probably encompasses most of that.
We need to focus on where the biggest gains are to be made and what do we think is ready for standardization. I am not sure that the envelope in transmission is ready because we are maturing. New technology is coming along. I am not sure of a strong recommendation there.
I can be sure of a strong recommendation on gathering people together, having national consensus on what should be the content of a message that orders an
x-ray for a person or orders a drug. So, I can see strong recommendations that there should be the convening of expert opinion and development of a national standard for specific functions, recognizing that as technology changes and the practice of medicine changes, that will also change. But I see the need for developing a starting point and maybe an organization that monitors and supports and convenes and does this.
Those I see as firm recommendations.
MR. BLAIR: Bob, you had a comment?
MR. MAYES: Well, I actually, yes, wanted to make another, right along those lines. I think that is probably important for us somewhere, at least I think it is important for us somewhere to, first, at least internally here, but maybe even explicitly in the document, to recognize that there is a difference between internal systems and communication between systems.
Really, I think I would be safe to say that really the area that we are interested in and that, in fact, Congress and the Secretary was interested in was what might be termed that interface area. This goes to somewhat to Simon's concerns about architects, models and that sort of thing. I think it is important for us to realize that, you know, how you do something internally locally is really not the appropriate -- is not an area that we are addressing in here.
This is really how do you actually communicate something with someone else. So, there is a difference between how you run something internally and how you might have to do it -- I really don't care how you represent --
MR. BLAIR: Simon, you had a comment?
DR. COHN: Yes. I actually -- I had a very good idea and I, of course, forgot as we getting close to lunch. First of all, on a very practical basis, to my knowledge, these are not very mature standards. So, we can't, even if we wanted to -- I may be mistaken, but my understanding of the standards environment is is that I don't know that there are any standards that even if we wanted to do this tomorrow that we could -- yes, that we could say are so mature or so well implemented that they can be standards.
I think that there is work in this area, work which I actually saw partly being involved with Item 4, to help get that to the place where there could be standards.
MR. BLAIR: What is Item 4?
DR. COHN: Item 4 has to do with the whole issue of government promoting coordination. What I saw in No. 4 is improving consistency, reducing redundancy, identifying gaps in the overall data registry, data model, as I describe it, and beginning to work on that area. It is not something that -- you know, the government can provide leadership by internally coming up with standards for PMRI content, structure, architecture and shared information model, but if it were to do that, it would be the first time we would have one, at least I think, that we could say, gee, it really worked. There isn't one out there that I think that I can pull down and say this is a mature piece.
Now, Margaret A. had a comment on this.
MS. AMATAYARUL: Yes, Simon. There was actually testimony by a couple of people talking about HL7 standards specifically and they -- and I do recall that they mentioned specifically the Version 2.3 was mature as a standard for the purpose that it provided, but it was not -- it was, quote, unquote, an old standard and probably should not be adopted because of that, but that Version 3.0 was not mature enough yet. So, you were sort of -- I remember people saying that you were kind of caught in the middle because you have one standard that is not suitable and another standard that is not mature.
DR. COHN: Margaret, can I make a comment on this one because I -- once again, I am not the expert on HL7. I would have to defer to Jeff to, indeed, verify what I am saying, but both the Version 2.4, as well as the reference information model is an information model that has to do with message format standards. It doesn't have to do, at least as far as I understand with the content and structure, architecture of the computer-based patient record or -- gosh I am getting confused now. So, maybe I should just -- I guess it is my confusion of where one drops off and the other one drops on, but you may be right on that.
MR. BLAIR: We have to make a decision because our process for going through this is not going to work and either it is not going to work because it is not the right process and we have to come up with a process or we have to decide to focus on it. Okay? But at this point we have thought on our agenda that we would not only be complete with the message format pieces, but that we would be 30 minutes into lunch.
Now, that may be because we really have issues where our agenda just is not an appropriate agenda or a realistic agenda. So, I am going to solicit at this point some suggestions because if we continue to go this way at the end of this day we will probably not get to the other six focus areas at all by tomorrow morning.
So, could I have some guidance as to what our process should be with proceeding on identifying the issues and recommendations, specifically the recommendations.
DR. COHN: Can I make a comment?
MR. BLAIR: Yes.
DR. COHN: I think, first of all, it is time for lunch and I think you are beginning to see that in the way people are acting and the comments that they are making. I think that generally when we come up against hard issues, we may want to tag them and come back to them as opposed to trying to beat them to death, which is, I think, sort of what we are doing on this one. That is just sort of a suggestion.
I think, otherwise, the process is fine personally.
MR. BLAIR: Hold on one sec because I am afraid to lose everybody for lunch here.
PARTICIPANT: Ask for other opinions.
MR. BLAIR: Well, that is what I was going to do.
Could I have some suggestions, please, as to what you think is -- we have got a half a day this afternoon and we have got a couple of hours this morning.
DR. COHN: Tomorrow morning.
MR. BLAIR: Tomorrow morning. And you can see the issues the way Margaret has laid them out. Is there some suggestions so that we can make progress and build some consensus as to what our recommendations should be? How should we go through this process?
DR. FERRANS: A quick suggestion is that after lunch that perhaps we just want to go around the room and specifically with regards to message formats -- we are spending a lot of time trying to say, okay, what framework are we going to use to -- let's take a quick poll on what people think government ought to do, since I think there was agreement that government ought to do something, just to establish is there any baseline consensus and then move it that way.
I mean, that is one approach to doing it and if that approach fails, we can certainly go to another one.
MR. BLAIR: Okay.
And Bob?
MR. MAYES: I would actually point out as -- if you look through the rest of the document, many of the recommendations are far more specific than these first few. I think we unfortunately started off with some very generic kind of recommendations. I would go back to my early recommendation that we simply go right through them and sort of say are these -- you know, as Simon pointed out, are there -- are these things that are totally off the wall or are they things that we need to flesh out because they are not so specific or do we feel fairly comfortable and do that for both the issues and that and then we can prioritize after we have gone there.
Because when you look through some of these others, they are pretty specific. You know, this group should be funded. This thing should be billed. That thing should be whatever versus these kind of generic -- you know, what philosophical level should the government be involved in. I think it will actually move quicker if we don't let ourselves get bogged down up front.
MR. BLAIR: Any other suggestions as to how we proceed? I think I am hearing two different ones. One is Bill Yasnoff is saying let's identify specifically our thoughts on message format standards and
recommendations --
PARTICIPANT: Richard Ferrans.
MR. BLAIR: I am sorry. Richard.
And Bob is saying we should essentially -- you feel like we will catch up if we continue on going through the items.
DR. COHN: That is what Simon thinks, too.
MR. BLAIR: I am afraid we won't get beyond the message format thing and there is some good meat in the rest of this.
So, you think it will move faster?
DR. COHN: Yes, I think it will. I think No. 2 is -- I looked at it last night and you are hearing why I wanted to get rid of it because of exactly the conversation we are having. Not that it -- it needs to be put somewhere else, dealt with in a different way, but beyond that I think the rest of the things will move a little quicker.
Let's break for lunch.
MR. BLAIR: Thank you.
[Whereupon, at 12:22 p.m., the meeting recessed, to reconvene at 1:30 p.m., the same afternoon, Thursday, December 9, 1999.]
A F T E R N O O N S E S S I O N [1:30 p.m.]
MR. BLAIR: Clem, you have something that you wanted to share with the group to make sure that it was included.
DR. MC DONALD: Well, I thought I would send a document, but I have written some of it. Basically, I don't like much of this document. A lot of it is mixing up things in different ways. There are too many points. So, we have a lot of work to do, I think, unless everyone else loves it.
MR. BLAIR: Can you help us with it?
DR. MC DONALD: Yes, I will do what I can, but I -- I mean, I think there are factual mix-ups and there are several things. This is not a big point of the document, but I am going to send a document that will deal with some of it, but it is saying that physicians don't use information. Well, that is false. And it goes on and on like that.
I think I will just participate in the discussion of the issues, if I may, for as long as I can and I can hear you and you can hear me.
MR. BLAIR: Clem, can you send us that document? I mean, if we could --
DR. MC DONALD: I am going to send you a document. It only covers the first four pages. I will send it.
DR. COHN: That is fine. You are able to make comments. We are not voting on a final draft today, I don't think.
MR. BLAIR: As a matter of fact, this is not even the first draft. This is the ideas that we -- we are trying to get the ideas in place, so that we can create a first draft. Was that clear to you?
DR. MC DONALD: I don't know. But in any case, it is going to be a lot of work.
MR. BLAIR: Yes, absolutely. There is a tremendous amount of work.
Okay.
DR. MC DONALD: Let me just -- can I just talk real short about 1 and 2 and it is sort of the casting --
What we really want to do is avoid bilateral agreements with implementation guides and that works pretty well in this day and age. So, all the rest of the stuff is just confusing. And plug and play is a hardware issue. So, avoid bilateral agreements and have good enough good enough implementation guidelines we don't have to have them.
MR. BLAIR: Okay. I have heard plug and play
-- interoperability is a phrase which is a spectrum and the ultimate interoperability would be plug and play. It was meant in that context.
DR. MC DONALD: Yes, but it sounds like we are the only ones that aren't doing that. It sets the stage -- it sets the bar higher than is necessary to achieve the goals of the HIPAA request and that is to standardize clinical data. NCVHS isn't plug and play, but everybody is using it.
It is a key thing that is sailing now is that we do have bilateral agreements and there isn't tight enough implementation guides. I am not saying we couldn't say we want to aim for that, but the thing -- the recommendation is casting this all in negative terms, which all the successful standards at the similar level are not aiming -- are not doing plug and play. That is we will always be a failure if we say that has got to be our goal tomorrow.
DR. COHN: Clem, if I can break in, I actually do -- to move away from the wordsmithing issues of No. 1, actually, I am really glad to hear that you strongly support the idea of implementation guidelines and guides.
DR. MC DONALD: I am supporting the recommendation. I think we confuse it with the background.
DR. COHN: Great. Okay.
Did you have any comments or can we move on to Issue 4?
DR. MC DONALD: Yes. Go ahead.
MR. BLAIR: Okay. Margaret.
MS. AMATAYARUL: Jeff, do you want me to go on to No. 2 in message format standards? Is that what --
DR. COHN: No. No. 4.
MS. AMATAYARUL: No. 4. Okay.
No. 4 is several testifiers felt that the limited market acceptance of PMRI message format medical terminology standards was due to a number of factors: (1) confusion in the marketplace as a result of inconsistency; (2) limited implementation capability and (3) diversity as a standard.
Additionally, some vendors and users are unaware of some of the available message format medical terminology standards. Finally, the fact that some message format medical terminology terms are not designated as an American national standard may be impairing their market acceptance.
There were several recommendations. Government should promote coordination among message format standards and medical terminologies by formally recognizing and providing appropriate subsidies to ANSI HISB for the following activities: (1) the development and maintenance of an open health care data registry based on the ISO11179 standard for meta-data, which would include the data elements from the major health care message format standards and information model.
Do you want me to pause after each recommendation or just keep going?
DR. COHN: No.
MS. AMATAYARUL: Okay.
(2) Support for conferences and workshops to determine the best way to converge reference information models for message formats with the content of referenced medical terminologies; designation as an American National Standard for PMRI message format standards and medical terminologies; promote the evaluation of potential overlaps and the development of standards needed to fill gaps.
DR. COHN: Can I make a comment or two?
MR. BLAIR: Yes, go ahead.
DR. COHN: I was actually going to suggest, first of all, that we discuss this in sort of two different frames. I mean, one is is something like this necessary and then the other question being is do we have recommendations on who ought to be doing it? I think it is a useful way to think about -- I guess I would start out by saying that I support the idea of this, though I question this issue of what designation as an American National Standard for PMRI message format means in this context.
It isn't clear to me what that recommendation is. I also believe that this role to be truly effective needs a responsibility to be looking at issues of consistency, non-redundant -- issues of consistency, redundancy, as well as gaps in the overall area and potentially making recommendations to the appropriate body, be it NCVHS or other body in terms of ways to address the gaps and the other issues.
So, I think that there is an additional responsibility that probably is not listed there.
MR. BLAIR: Let's see if Margaret can capture that thought. I wasn't exactly sure -- can you rephrase what the thought is that she should capture as the additional idea?
DR. COHN: I think that other --
DR. MC DONALD: Could I comment on that one?
DR. COHN: Let me just get the thing down and then we will --
MR. BLAIR: Let Simon finish with his thought.
DR. COHN: Yes. That I thought that the -- whoever it is that does this, there is a responsibility
-- rather than just having a registry, there is a responsibility that somebody needs to be looking at issues around consistency, redundancy, as well as identifying gaps and making recommendations to the appropriate body or bodies about that. That was just -- it felt to me like part of the role.
MR. BLAIR: Okay. And then the other point that you had was you wanted to get clarified ANSI HISB. I think that there was a phrase -- ANSI HISB or, excuse me, ANSI accreditation, I think, and the word "accreditation" wasn't in there or something?
DR. FERRANS: -- board in No. 3, should it be a national standards board or something like that?
MR. MAYES: No, it already is a board. But designation as a national standard can only be done by ANSI.
DR. MC DONALD: Could I speak to this point?
DR. COHN: I don't know what 3 means yet. I mean, maybe you can --
DR. FERRANS: It should be agency or --
MS. AMATAYARUL: Would it help for me to explain the American National Standards? Simon, you had given us some language that ANSI HISB had come up with at the last meeting and that there are some standards that are accredited by ANSI and they become what is called American National Standards. That is, ANS is like an official term within ANSI.
DR. MC DONALD: No, that is not correct, Margaret.
MS. AMATAYARUL: Okay.
DR. MC DONALD: You can be accredited as an -- you can be an American National Standards organization, being an American National Standard is another step. X12 is an American National Standards organization. They have never submitted the standards to ANSI, to make them ANSI standards. The only medical American National Standards now are HL7s and MID.
So, there are two different -- there is a distinction between the standards organization being accredited and the standards being approved.
MR. ZUBELDIA: Let me correct that just slightly. ANSI has submitted -- I am sorry -- X12 has submitted up to Version 3 as ANS.
DR. MC DONALD: Okay. I take it back, but just being a standards organization doesn't make you an ANSI standard.
MR. ZUBELDIA: -- specifically 4010 is not an ANS.
MR. BLAIR: I think the point of Margaret's piece here was she -- the whole point of this thing is things that are impacting market acceptance and the point on this was that one of the things that was impacting market acceptance was that some standards and terminologies were not accredited. In that case, the accrediting body was ANSI.
DR. MC DONALD: I think the antecedents to this thing are all wrong. I would like to speak to them.
Firstly, that is not true. Internet is not an ANSI standard. And it hasn't had any trouble with market acceptance. X12 has not been in the past an ANSI standard. It hasn't had any trouble with market acceptance.
I think that the whole issue side of this is confused and mixed up and I think the whole bullet should be revisited, the whole section. If you are putting in the vocabulary and the message standards together, you are going to create lots of problems. Saying that they are not accepted is not true across the board. There is very strong acceptance for NCPDP, for X12, for HL7, as message standards. There are problems with some vocabulary standards, but some of it has to do with their life cycle, where are they on their life cycle.
I think the antecedents on this have just been made up. I don't think they are true.
MR. BLAIR: Well, they weren't made up. Margaret was culling these things from the testimony. There were people that testified.
DR. MC DONALD: Well, they are interpreted in a way that I think is inaccurate then. That is, when you blur them altogether, you are going to get these true statements out, but you have blended together vocabulary and message standards in a way that makes it impossible to untangle what was said. And inconsistency of what? And a limited implementation capability of what? And diversity of the standards and why is that necessarily a problem?
You know, there are different standards for different purposes. So, I think this whole set of antecedents is not correct and I would like to see the data or the testimony that said this in the strong terms. When you mix the vocabulary, it is true. The vocabulary standards aren't well-accepted, but some of them are very, very new. And there are other issues about -- it also implies very heavy coding work, which might be a work issue rather than a standard, the stuff itself.
I just think that the antecedents are problematic and now we are setting solutions when the antecedents are all messy.
MR. BLAIR: Could you maybe suggest some words for Margaret that --
DR. MC DONALD: I think they should be redone and they -- you need to decide what is true. I mean, to say that -- to make the statement they are not accepted because they are not ANSI, where is that coming from? Where is the support for that statement?
MR. BLAIR: Margaret, maybe you could answer.
DR. MC DONALD: I mean, I just recall the Internet is not an ANSI standard. None of the Internet standards are ANSI standards.
MS. AMATAYARUL: What we were looking at, Clem, was basically the testimony that this work group heard. So, it was not intended to be standards for the world, but solely for health care informatic standards.
DR. MC DONALD: But I still don't recall hearing that particular statement by testimony people.
Can you cite it?
DR. COHN: Clem, this is Simon. I actually agree with you that the -- I mean, there is an issue here but it may not be the one that is being exactly referenced here. I think I would agree with you that the final sentence having to do with something not being designated as an American National Standard is probably not relevant to the discussion, I think. Or I would have to be convinced that it really is relevant, but there is an issue that there is a lot of standards out there and some of the standards are -- I mean, many of the standards are sort of confusing to the marketplace.
DR. MC DONALD: But we have got to be specific because you are tying the whole field in ways I think is inaccurate from what I see it. I can get certain standards across the board. If I buy an outpatient pharmacy system, I will get NCPDP in it and I can use it and I am using it.
Any of the clinical systems we bought in the last years come with HL7 standards. For those parts of the X12, we get X12 standards. So, we are tying the thing in a way that I think is not accurate. Then we are saying we are going to create this structure, which hasn't been a blooming success now and now we are going to fund it. I think these standards groups should have some say in whether they think that is a good idea or how they should best get it coordinated.
If there is a problem with coordination -- I mean, I think we are creating a problem that may not really exist. At least these antecedents, if you -- we need to discuss the problems of vocabulary separately from message standards. There are different sets of problems. You couldn't make an ANSI standard, I don't think, out of a vocabulary because you can't do the voting process you would need every time you get a new term come in.
MR. BLAIR: Clem, the only thing I have difficulty with is that Margaret, when she culled through the document, she has a work document where she referenced the source of each of these things and then the ones that -- you know, from my understanding of the way -- of her process -- and correct me if I am wrong, Margaret -- was that you then took those not that were just incidental, but you took the ones where several testifiers did and they were -- Clem, there was a difference between what SDOs were saying and what vendors and users were saying.
I do recall more than one vendor referencing the fact that they wanted the committee to, you know, not only adopt -- excuse me -- to reference -- you know, be proactive in adopting and indicating which ones would be appropriate, but that many of them indicated that ANSI accreditation was a criteria that would make them feel more comfortable.
So, Margaret did not pull those out of the air, you know. There were people that testified and for the most part I think it was the vendors.
DR. FERRANS: Clem, this is Richard.
I think one of the -- I think perhaps if that was -- I think what I heard in the testimony is people saying that if there were national standards -- and forget about American National Standards, but if there were national standards, then that would -- that that would certainly improve market acceptance for the product.
DR. MC DONALD: I agree with that.
DR. FERRANS: And then if we -- I do agree if we break it down between message format standards and medical terminologies on that, then we will find some different issues there.
I do think that -- let me just stop right there.
MR. MAYES: This is Bob Mayes, Clem.
Earlier in the day we had a discussion. I had a concern that we not -- that we are leaving content out of here if we strictly refer to terminologies and message format standards.
DR. MC DONALD: We are leaving what?
MR. MAYES: Content.
DR. MC DONALD: Well, I am not saying we won't want to talk about it. I am saying that when you start to make the statements about standards and you say them applied to those different areas, you can't say true statements very accurately.
MR. MAYES: Right. And I am just saying there is the third area, which is the standardization of content.
DR. MC DONALD: Yes.
DR. FERRANS: I would just also -- and actually I would just also add the issue of coordination among standard development organizations. I do think that there was testimony that there was a lot of agreement that the government needed to come in and help coordinate the coordinating --
DR. MC DONALD: I feel this is about government meddling because they get confused. The government doesn't understand and I think some of this stuff reflects poor understanding of what is happening out there right now, is Item 4. And all we are going to do is screw it up if we meddle. I don't like -- I would just as soon see 4 go away and start all over again. I don't see that the antecedents are connected.
We are saying here are a bunch of problems. So, we are going to do this and I basically vote against 4. But maybe --
MR. ZUBELDIA: This is Kepa. Would you volunteer to rewrite 4?
MR. BLAIR: He is saying to completely eliminate 4.
DR. MC DONALD: I am saying eliminate it and come back with something that is clean and clear and is crisp and is dealing with issues we can look at the antecedents and say, yes, that is true and then say this is what we need to solve.
MR. MAYES: By example. What is an example, Clem?
DR. MC DONALD: Of what is not true?
MR. MAYES: No, no. Of a clear and concise issue.
DR. MC DONALD: Well, I think there are some further ones down here. We need a unique patient identifier. I mean, we talk about standards being coordinated and we talk about the problems of standards, well, hell, how the hell can you do a plug and play across an institution if you have got different patient numbers, no matter what the standards do?
MR. BLAIR: Is there another one that hasn't already been addressed in legislation that jumps out at you?
DR. MC DONALD: We have got 30 of them in here, don't we?
MR. BLAIR: Well, I know, but I didn't know whether you were going to have the same comment for the remaining 20 --
DR. COHN: Clem, I guess from my own view when I saw this, to me the issue was is that there needed to be a look for -- this is Simon Cohn -- to me the fundamental issue was is that if we are going to move forward with national standards that are really interoperable and more or less complete and solve the marketplace needs, that there is a need someplace, since we are dealing with multiple different terminology developers, even if we are just talking about the HIPAA-mandated terminologies. There is a whole issue of coordination there. There is an issue of redundancy, overlap, as well as gaps.
DR. MC DONALD: Oh, the vocabulary has a whole lot of issues. No question.
DR. COHN: Well, no. I was actually referring to the -- I am sorry. I meant the message standard developers. I wasn't -- and I guess and in its relationship to terminology, but you are referring to the message format standards.
DR. MC DONALD: My disagreement with 4 is not a specific thing. It is just that I think it is so -- it is muddled and I think it can't lead to clarity. We should clear it out and start over. When we have got specific issues about vocabulary, we should say it, they are about vocabulary.
MR. BLAIR: One of the things, Clem, that happened over lunch is as you realize we are close to two hours behind or maybe even more than two hours behind and part of it is the -- excuse me. Let me make sure you all agree with this. Okay? Part of it is, Clem, what the intent was of this and the feeling is that this is not the first draft. This is a process for us to help Margaret pull together what the recommendations should be and when -- you know, the process she used was to go through the testimony and cull it out that way.
Then this second step that we are trying to do today is say do those recommendations -- are they appropriate for those issues. We do know that these are not mutually exclusive issues and that that -- I don't know if we can reconcile all of that in a -- go ahead, Clem.
DR. MC DONALD: You are not going to make me happy with No. 4. I mean, there are two sides to it. On the one side you are saying things on the left side that you think are true. I mean, just as an intellectual statement these are just assertions out of the blue that don't connect and aren't well-stated.
On the other side, you are saying HISB should be the person that does this. Those are two different issues. First, we don't have antecedent that I buy and, secondly, I could also argue with whether HSB should be blessed with any new control funding or power unless those organizations that it really has to influence have a strong belief that it would work for them. That will be X12, HL7, NCPDP, et cetera, because it won't matter if they don't.
MR. BLAIR: You know, this is one of those frustrating areas where because I can't see and I can't read that thing to verify these things, I can't clarify. But is No. 4 indicating the need for coordination?
DR. MC DONALD: No. 4 is mostly saying that HISB should do all this stuff and get funded. Coordination. Have workshops. You know, do a registry, et cetera.
MR. BLAIR: Okay. Is you problem with the fact that you don't even believe there is a need or do you believe --
DR. MC DONALD: Well, the problem I have is --
MR. BLAIR: -- the problem is that ANSI HISB you don't think is the right entity?
DR. MC DONALD: I think the combination is deadly. It starts out saying several testifiers felt that the limit of market acceptance of PMRI messages format and medical terminology standards was due to a number of factors. It begs the questions.
There is not a limited market acceptance of PMRI messages in many of these fields. It simply is not true. When you add the medical terminology standards, it gets to be more true. And then it goes on to a whole bunch of explanations for it. Gee --
MS. FYFFE: This is Kathleen. I am sorry to interrupt, but I am getting nervous about our time frame here. Is there a way that we can put block No. 4 on the warm burner and let Margaret and Clem talk about this and then continue on with the other items so that we can get through this?
DR. MC DONALD: I would like that.
MS. FYFFE: Yes. Thank you.
MR. BLAIR: Let's go to No. 5. Item 5.
MS. AMATAYARUL: Okay. No. 5 is some testifiers indicated a need for more leadership for coordination among message format standard and medical terminology developers. Current efforts tend to be bilateral and somewhat multilateral, depending on the needs of the developers at the moment and not as multifaceted and comprehensive as they should be.
The recommendations were including those in 4 above, as well as the government should formally recognize and subsidize ANSI HISB as the oversite organization where a collection of repository of standards activities is maintained and used to harmonize these activities.
There is a note that says ANSI HISB has compiled an inventory of standards but does not maintain it or use it in the manner suggested.
MR. BLAIR: I am sure Clem supports this one. Clem, are you there?
DR. MC DONALD: Yes, but I don't think I should be talking all the time.
MR. BLAIR: What are your thoughts on this one?
DR. MC DONALD: I don't think that it would help to be given official authority of ANSI HISB to push around the standards groups.
MS. GREENBERG: Can I say something? This is Marjorie. I also just joined after lunch.
I think I understand what is going on here. I am not completely sure, but -- and I don't know how it went before I got here, but it seems that -- I mean, I -- taking as a given that Margaret went through the testimony and pulled out what she saw as concerns that people raised and findings, in a sense -- that is what we are talking about on the left side, the issues, the findings, and it seems to me that it would be fruitful to agree on the findings before you start -- whether that really is a problem or as Clem said, he felt that in some cases on the previous one, it wasn't even a problem, and whether that is an area where you want to have a recommendation because it seems there is going to be a lot more heat over the recommendations, but maybe --
DR. COHN: Marjorie, can I make a comment?
MS. GREENBERG: -- better to agree on the findings?
DR. COHN: Can I make a comment? We actually had a conference call regarding the issues.
MS. GREENBERG: Oh, the whole group did?
MR. BLAIR: Yes.
DR. COHN: Unfortunately, I think Clem was --
MS. GREENBERG: I am sorry. I didn't realize that. I know you said you had spoken with -- okay. Well, then I withdraw my recommendation, but it -- because it seemed like there wasn't even agreement on some of the findings.
DR. COHN: Well, what has happened is unfortunately not everybody was able to be on the conference call. I think there is still some conflict and certainly there needs to be improved wordsmithing on it.
DR. YASNOFF: Can I make a process suggestion? This is Bill Yasnoff.
Why don't we just go through these and see if there is consensus on any of these? We can just go through them one at a time and we can say, okay, does everybody agree with that, yes or no. Maybe there are none that we agree on, but maybe there are 15 of these that we agree on. I don't know.
DR. COHN: Okay. Well, can I make a comment about 5 just very quickly before we move on? Because I actually think it is the same as 4. And I am not sure that I see any difference. And knowing that we have 43 of these, if there is any way to reduce them to 42 or 41, I think that should all make us feel proud.
So, I think it is very much the same as the Item No. 4 and probably putting those together might actually create something that makes a little more sense.
MS. AMATAYARUL: Simon, can I just make one comment also, just to follow-up on what Marjorie said.
The recommendations were also culled from the testimony. So, these are recommendations that specific people made, you know, more times than just once, basically. So, that does also reflect the testimony.
DR. YASNOFF: This is Bill Yasnoff again.
But as Bob Mayes pointed out before, we are not obligated to follow the testimony at all.
MS. AMATAYARUL: Absolutely.
DR. YASNOFF: We do not have to justify what testimony we accept, what testimony we don't accept. That was just advisory to us. So, we need to keep that in mind.
DR. FERRANS: I would also add that this recommendation might have been made by ANSI HISB, but in any case what is actually important here also is we may want to tease out -- if you take the name of the organization off it, is this something very useful? Because I think it is. Then we get on to the discussion of, okay, well, then what is the problem with the particular entity or not the particular entity or is it not a good activity at all because we need to try and find out what the real issue is.
Is it that we are picking an organization or a standard or that we shouldn't be picking anything at all and let the loose confederacy of SDOs continue the incremental process?
MR. BLAIR: No. 6.
DR. MC DONALD: Well, I would like to hear from our X12 member. My perception is that the standards organizations are doing pretty well and the market is sorting things out pretty well right now.
But I would like to hear from others, who have a different perspective.
MR. ZUBELDIA: Clem, this is Kepa.
I guess you were referring to me. X12 has done very well without being ASC standard -- I am sorry -- ANSI standards. None of the 4010 are ANSI standards and they won't be for another five years or so. X12 has done well without much coordination with NCPDP, if you want, although a lot of the NCPDP members are also members of X12 and have been informally working in both places.
X12 has also done well with the coordination with HL7. But, again, because of the people involved in it were also in both places. But, for instance, there is no coordination with DYCOM(?) and with some of the other clinical standards.
My understanding of HISB is that that is supposed to be the role of HISB,not just to have an inventory, but to actually provide a coordination about whether the standard setting organizations follow the recommendations of HISB, whether they pay any attention to what HISB tells them or not. That is their business.
I think they should be, but if they don't, that is a different problem. Maybe as part of our recommendations here we should recommend that the clinical standards should pay attention to the HISB coordination, which is to recommend HISB to coordinate the process.
DR. FERRANS: Kepa, this is Richard.
I would say one other thing is much more important in my opinion. I think, the -- again, getting back to what we said earlier today, the overwhelming opinion of the testifiers that we heard is that the government needed to do a role because the process wasn't moving fast enough.
I don't want to use the term "market acceptance," because I think it is very confusing because we are talking about terminologies and message format standards. I think HL7 has a lot of market acceptance, but I think market acceptance is, quote, unquote, not the issue there.
But, again, I think the consensus was is that it wasn't moving fast enough. So, there is some -- if there is some way to coordinate and accelerate, I think that is something that the testifiers really wanted across the board.
DR. MC DONALD: I would agree that there was a real wish that it could go faster and I thought there was sentiment for and against funding and the funding was not just to a coordinating group, but to help the standards move faster and there are some other bullets on that later on.
MR. BLAIR: Margaret, can you continue?
MS. AMATAYARUL: Yes.
MR. BLAIR: I am sorry. I didn't want to cut off any other discussion.
MS. GREENBERG: Well, just to clarify, I assume what Bill was saying is the subcommittee, the work group, the subcommittee, the full committee certainly doesn't have to accept people's recommendations that were made in testimony. They were advisory.
I would think, though, that the findings that came out of the hearings you have to respond to in some way and if you actually don't feel you have got adequate findings, you would have to hold more hearings, which I don't think you probably have to do or want to do.
So, the distinction about the committee doesn't really have to follow what was heard in the hearings, I think the findings are -- need to be responded to, but not necessarily with the recommendations that people made. I think the recommendations come out of the committee.
MR. BLAIR: Let me add just one other thing here -- and Simon had actually made this recommendation and this may be a very appropriate part to mention it -- and, Clem, this is addressed in part to your suggestions and your thoughts here.
Margaret, when she compiled these things, she identified each individual person that testified in these things and Simon's suggestion was that especially when there is controversy, like here, the views of the SDOs in this case, where in -- you know, many of them may wind up saying, well, we don't need to be coordinated and everything is fine, where it may have differed from the testimony of vendors and users.
If when Margaret -- Simon was suggesting that Margaret give us a little bit more detailed information, like maybe on this type of issue, as to the source of the folks that were winding up making these recommendations that she included in here and I think it may be important to us if the users are winding up saying that there is a need that, you know -- where that differs from the perception of the SDOs. I think it may be useful for the -- do you agree, Clem, that that --
DR. MC DONALD: Well, I agree it would be nice to know who proposed that the ANSI HISB do this. I would like to know that. I think that the more general statement is this is America and you don't -- you have got to have people agreeing to be controlled.
MR. BLAIR: Margaret, are you able to maybe pull that out of your database?
MS. AMATAYARUL: Jeff, I did that for the issues and have a document that has probably got four or five hundred statements and, you know, who is associated with that. When I got to the recommendations, I went back and, you know, basically highlighted through the testimony. I did not compile a separate list of those. I moved them directly to this document.
So, I can't today go back and say this recommendation was made by, you know, x number of people, but I can certainly do that for another time. I just can't pull it up today.
MR. ZUBELDIA: This is Kepa.
Could I make a task to do off line for either Margaret or Clem to verify with ANSI what is the charter of HISB and what is HISB supposed to do? Because I understand that ANSI has designated HISB as the coordinating entity for all the health care ASCs. So, if you are on ASC from ANSI, you are subject to ANSI's requirement to coordinate with HISB your health care activities. That is my understanding.
But I would like to make that task to be researched off line and reported to the next meeting.
DR. FERRANS: I would just also add in the statement -- and I certainly agree with the "in America" part that people should agree to be coordinated or whatever. On the other if there is consensus that that event is not going to occur, then is there another process given that the benefits are clear and measurable and I think that is one of the fundamental issues that needs to be discussed here. That is why people talk about what the role of government is. It sort of gets us back to the very beginning of the discussion. What are the remedies that are available and are they appropriate.
I think, again, Clem, it is important and your point is very well-taken that we cannot generalize and that we have to get very specific with regards to whether we are talking about, you know, one specific area or another, not just lump it altogether and say, well let's let, you know -- because in some areas the process is working.
DR. FITZMAURICE: Clem, this is Mike Fitzmaurice.
I think one of the issues is with regard to the issues is not so much did somebody say them, but did somebody say them and do we believe them or should they be put together in some other framework?
Then, secondly, what actions are called for? Some of the actions that are recommended might be good actions, but not well-supported by the issues as they were described.
Thirdly, who should do them? So that we want a discussion of should it be HISB, should it be CPRI, should it be a government agency, should it not be done at all or maybe there is another option. We are looking for things that will improve interoperability, that will improve communication, make messages known with better certainty by better definitions of the term and use of nomenclature.
So, in that regard, I think we are moving in the right direction. Some of the things may not fit as well as you would like them, but I would really welcome suggestions that get us moving toward accelerating standards where we can and empowering the standard developing organizations to move faster, charging some people with identifying the gaps and promoting collaboration to do it and then telling the government, look, some parts of this are public good and you should be putting money out there, either funding SDOs directly through grants and contracts or indirectly by buying what they produce.
DR. MC DONALD: I support 99 percent of what you said there, Mike. And there are -- we have got a lot of bullets here. I am going to be positive about some of these bullets. We ought to make sure we cover a lot of them.
DR. COHN: Maybe we should move on to No. 6 then. Is that timely? Okay. Everybody is giving the thumbs up sign.
MS. AMATAYARUL: No. 6 is the issue is several testifiers indicated that the lack of a unique patient identifier was a key inhibitor for authorized exchange of PMRI within and among providers and the recommendation is the HIPAA requirement for unambiguous person identification should be adopted as soon as federal privacy legislation is at hand.
DR. COHN: Gosh, could I make a comment on that?
MR. BLAIR: Amen. No. 7?
DR. COHN: Well, actually I was going to suggest that we delete this one, quite frankly.
DR. FITZMAURICE: As being outside our scope?
DR. MC DONALD: The challenge to this is that the success of standards is kind of dinged a lot because they are not plug and play. Standards can be whatever they want to be. They can actually make a machine that is plug and play, but you are not going to know who you are talking about if the patient numbers aren't the same. So that we have these sort of conundrums, you know, where you are damned if you do and whatever you do, you are going to be blamed because you can't do it right because of external forces that prevent you from doing it right.
MR. BLAIR: Simon, could you clarify why is it that you feel like we should delete this?
DR. COHN: Actually, because I thought this is probably an issue that is going to be on a completely different track and it is controversial enough that it could easily take attention away from any of the other recommendations.
MR. BLAIR: Like it is beyond the scope of the standards for PMRI?
DR. COHN: Well, I guess the group can decide. I mean, I think it is -- I guess in my view, yes. I mean, I think it is an overall HIPAA standard. It is actually already in legislation.
We have actually just been unable to pull it off. So, it is not likely to be a clinical data standard that is going to be coming through. Now, we could make someplace in the body of the text background indicating that this might be a helpful piece. I think I would maybe move away from saying something that it should be adopted as soon as federal privacy legislation is passed.
MR. BLAIR: Could I make this suggestion because I think I understand your point and I think there is validity to it. I think there is a balance we try to create here. Okay? And the balance is that -- we did receive a lot of testimony for a whole year and apparently this is one of the things that came out more than I realized in the testimony and Margaret represented it. What if we were to in that section, where we wound up indicating valid concerns that are out of scope, that we put it there so that at least it is not referenced in the document. But we considered it out of scope of uniform standards for PMRI and addressed otherwise -- would that do it?
DR. COHN: That would be fine with me.
DR. MC DONALD: Could I suggest a different approach because -- I mean, the thing that the -- what the requirements of D says, it says we shall study the issues related to the adoption of uniform data standards for patient medical record information and the electronic exchange of such information.
This particular item is central and absolute and completely required for that, I think, and it is an issue that is true and accurate, so that where we could soften the recommendation, we might be able to achieve both goals.
We could say that we will encourage work toward a way to identify patients across communicants. Because if we ignore this, we are kidding ourselves. If we are ignoring that it is not an issue, we are kidding ourselves about achieving the goals and what is in the HIPAA legislation.
MR. BLAIR: Could we then do this then so that we move on? Could you mark this as an area where, you know, maybe at our next meeting in January 1, after it is, you know, written up, we could actually vote whether to keep it in or not?
MS. GREENBERG: Could I suggest -- I mean, can I say something?
MR. BLAIR: Would that be all right?
MS. GREENBERG: I think to say it is out of scope is ridiculous, actually, for the reasons that Clem said. On the other hand, I think that probably what is here is too strong. It would be hard to get everyone around to consensus since there are some people that think there are ways that this problem can be solved without a unique patient identifier. I have never been exactly clear what those ways are, but -- so, I just think it should say it should be addressed as soon as federal privacy legislation is passed and addressing it is holding hearings, looking into ways to solve it.
You can't even address it now because of the lack of privacy legislation, but it doesn't seem to me too -- I mean, I would certainly think it would be problematic to say it is out of scope.
What strikes me is that I remember when the IOM report came out and it really struck me that one thing that was completely absent from that report was any recommendation on a unique patient identifier. It does seem like sort of how do you bring it altogether without it. Yet, obviously, they avoided it and here it is, I don't know how many years later, and we still can't talk about it. It is interesting.
But I think it should be addressed.
DR. FITZMAURICE: Could I just make a suggestion? I agree with what Marjorie said and if we take out the HIPAA requirement and simply say that a requirement for an unambiguous person identification should be adopted, it is essential for accurate exchange of clinical information about a patient. We don't have to tie it to the specific HIPAA recommendation, but it is important that you know about whom the patient medical record information is about.
DR. MC DONALD: This is Clem again. I will be happy if we just tone down the recommendation in some way, either Marjorie's way or Mike's way. We don't have to say -- I think it is very important to not forget this because otherwise we will never send information easily, no matter how plug and play anything is.
MR. BLAIR: Who would volunteer for a phrasing of this, to do a phrasing?
DR. MC DONALD: I thought Marjorie's was actually quite good. If you would say that it would be addressed after -- we could out the HIPAA requirement. We could just say, you know, the person identification problem will be addressed after the federal privacy legislation is passed.
DR. COHN: I think Margaret is wordsmithing and I will read this to you, Jeff, because you can't see it, which has said "Encourage work towards, address unambiguous person identification." Is that right?
DR. MC DONALD: That is pretty weak.
DR. COHN: -- potential for communication about patients. I guess this doesn't quite sound so great. I guess I think it needs to be toned down. I guess my other comment is that it might be appropriate in the background. This is almost one of those barriers.
MR. BLAIR: Could we just leave this? Marjorie, would you mind writing a sentence or two and giving it to Margaret and -- you know, since people seem to feel like your statement was pretty much right and then we can maybe move on to the next item? Is that okay with the group? Is that all right? Yes? Is there a nodding of heads?
PARTICIPANT: No one is saying "no."
MR. BLAIR: Okay. So, Margaret will contribute a sentence to Marjorie. Marjorie will contribute --
MS. GREENBERG: Margaret and I will communicate.
MS. AMATAYARUL: We will collaborate.
MR. BLAIR: What is the next one?
MS. AMATAYARUL: No. 7 is virtually all testifiers urged that message format and medical terminology standards be kept technology neutral, especially as PMRI will have a longer life than any specific hardware or software technology.
The recommendation is the government should adopt guiding principles so PMRI message format and medical terminology standards that include the principal, that they be technology and vendor neutral because technologies change constantly and it is impractical to continuously change implementation.
Information should be structured in terms of a shared information model that allows the information to be reused for multiple purposes. Then there is a note. Semantics should not change. That is, the common point of reference and agreed-on set of terms to describe it, while syntax may change; that is, the set of rules for organizing words and terms and coding them without loss of meaning.
MR. BLAIR: I think that this is already one of the guiding principles, Michael, in your list. Is that correct? That it be technology neutral?
DR. FITZMAURICE: Yes.
MR. BLAIR: Okay. And I am saying that because if people are concerned about the additional sentences in there, then maybe we could just stick with the guiding principle that has already been adopted.
DR. MC DONALD: I would argue for that because, you know, you can't disagree with this, but it is hard to know what exactly it means in the operational sense.
DR. FITZMAURICE: In saying that, does that mean that we believe the information should not be structured in terms of a shared information model?
DR. MC DONALD: That is a different bullet.
MR. BLAIR: That is a different -- that is an expansion of the thought and --
DR. FITZMAURICE: I am willing to consider it is a separate bullet.
DR. MC DONALD: I think we are talking -- I thought I saw models discussed later.
DR. FITZMAURICE: I didn't want to lose that thought. I guess we agreed to delete this. Right?
MR. BLAIR: Delete the shared information model and just keep the -- essentially that first sentence, which is a paraphrasing of what I think you already have in the guiding principles.
DR. MC DONALD: I thought we have -- are those not going to be in the front of all this, the guiding principles? Is that going to be a part of this?
MR. BLAIR: Clem, when we gave the letter to the -- the progress report letter to the Secretary in September, one of the attachments to that was a modification of the guiding principles that had been used way back when for the financial administrative transactions.
DR. MC DONALD: Yes.
MR. BLAIR: And Michael had modified those so that they were a little bit more pertinent to patient medical record information.
DR. MC DONALD: They were fine. The question is is that going to be incorporated by reference to this document when we finish it?
MR. BLAIR: Well, yes. And we were kind of testing it. As Margaret was taking us through all of these recommendations, we were winding up seeing whether we needed to add any additional guiding principles. So, that is part of the process. Does that make sense, Clem?
DR. MC DONALD: Yes.
Okay?
DR. FITZMAURICE: Well, I am wondering, does it make sense to delete it; that is, delete the first part of it because it is already part of -- one of ten of our guiding principles?
DR. MC DONALD: That is what I was thinking. You don't need it here.
DR. FITZMAURICE: So, we emphasize the guiding principles. We don't emphasize one of them in a recommendation.
MR. BLAIR: Okay. So, it is already covered. We have already got it.
DR. FITZMAURICE: So, I was thinking of deleting the first half of it.
MR. BLAIR: Margaret, does this violate any of the -- you know, since you have pulled this together with -- you know, is that sufficient to cover the thoughts that you heard from testimony?
MS. AMATAYARUL: Yes.
MR. BLAIR: Okay.
DR. FITZMAURICE: Well, I mean, the issue could be raised when we talk about the guiding principles and say we got testimony and just put virtually this issue after we go through the guiding principles and say, yes, they recognize this and they testified.
DR. COHN: Gosh, I apologize. I am just a little bit confused. I think what we have done is we have just sort of said that is -- this area is handled by that one sentence in the guiding principles and we are just going to make sure that we put somewhere in the report sort of that these are really guiding principles that the CPR work group used to make its recommendations and we recommend these guiding principles for future decisions in this area probably and this is one of them. Is that correct?
DR. FITZMAURICE: And that, in fact, we did receive in testimony support, particularly for this one.
MR. BLAIR: Maybe that is the key point is that the testimony gave additional support for this guiding principle.
DR. COHN: Well, but I think they gave support probably to all the guiding principles when they went back and looked at them probably.
The only question I have then is that there is a sentence here that I was trying to figure out whether we were deleting it or not where it says implementation should be structured in terms of a shared information model that allows information to be reused for multiple purposes. Is that still there or is that going away
and --
MR. BLAIR: No, that was the thrust of my comment is that -- because I figured that would generate another 30 minutes of conversation.
[Multiple discussions.]
DR. FITZMAURICE: But I understood that Clem said that is covered in a further point on down --
DR. MC DONALD: I thought it was. Maybe I am wrong.
MS. AMATAYARUL: I haven't struck it. I put a note that said also elsewhere, just to make sure that we didn't lose it.
DR. COHN: Great. Okay. Thank you.
MR. BLAIR: 8.
DR. MC DONALD: I like -- just to take a position like I hardly ever do, I like it, except I don't think that it is really right that we say making DOD, VA and public health models -- well, this is a difficult thing. The risk is, say, for the DOD model --
MR. BLAIR: Could you let Margaret read it first?
DR. MC DONALD: Oh, I am sorry. I thought we were all reading it. Oh, yes, I am sorry. I am sorry, Jeff.
MS. AMATAYARUL: Eight is many testifiers indicated the government has a role to play in facilitating the acceleration and harmonization of the PMRI standards development and the recommendations include the government should participate in accredited standards development organizations and consortia affiliated therewith, making DOD, VA and public health models available and promoting harmonization of a shared information model; that is, lead by example.
Also, the government should require use of accredited message format and medical terminology standards by government agencies involved in collection and dissemination of health care information and we also referenced 2B and 2C above.
Clem.
DR. MC DONALD: The only -- it is a tricky game but if one says the government has made up a model and then makes it available, that sounds good and friendly, but the government has already said in other parts of its voices, that it will work within the standards organizations and not come up with independent things. So, there is a little risk. You are encouraging it falling back to its old ways in that phrasing.
DR. FITZMAURICE: I am not sure that the government has said that it wouldn't come up with its own model or its own domains.
DR. MC DONALD: Well, the DOD model actually is not necessarily a great model for the purposes we are talking about. There is nothing wrong with them giving it away, but saying that it would become the national model is not -- it won't work and it isn't something you really want to be putting into a recommendation, I don't think. I think we want to encourage them to incorporate their ideas into the models being developed in the standards community. Otherwise, we are going to end up with a federal model and a private model.
DR. FITZMAURICE: To avoid that, Clem, would you advocate that we have a national model and should it be HL7's or somebody else's that we are going to build to.
DR. MC DONALD: You can't speak to that. I think it has to be what happens in terms of the organizations and the dynamics of the marketplace. There are many more than one model because there are different contexts that might require them. It is just that I just -- I think if we had said the government would make any of its models freely available, that is fine. But to suggest that they would necessarily be the guiding principle, I think, is not what you want. I have seen some of these models. They are not all what you want as a general --
MR. BLAIR: But I don't think that is what it says at all. It says make the models available and promote harmonization of a shared information model.
DR. FERRANS: And specifically, it is the FAM(?) D. I mean, what the GCPR is doing in terms of trying to come up with a data model is that they are trying to harmonize models from REM(?), FAM D, the Australian models and others and they are set up a CIG(?) in HL7. I mean, I think they are trying to do that. So, I think what they are referring to -- I think this is referring to the GCPR activities and not to the FAM D model from DOD especially.
DR. MC DONALD: Well, as I say, the sentiment is right. I just think that one has to still assert that this is a private sector activity, not a federal activity.
DR. FITZMAURICE: But given that, Clem, and I agree with it, should there be a federal support of developing a national set of models that can be applied in different domains; that is, a Christmas tree that everybody can hang from one branch or the other; a set of common concepts in terms that people can refer to, rather than inventing their own. They have shifted domains. In the vocabulary world, it is easier to speak of and describe and discuss. In the model world, it is much harder because it is such a beastly complicated thing. And it may --
MR. MAYES: How about a reference ontology then for health care?
DR. MC DONALD: If you speak specifically to vocabulary, I think, it is somewhat easier in terms of knowing what the domains and the specifics are. It is a long discussion, but no one has built a model that you can implement anywhere that everyone is happy with over
-- after 15 years.
DR. FITZMAURICE: Should the government try to build one for hospitals and one for physicians?
DR. MC DONALD: The government can't built one.
DR. FITZMAURICE: Support the private sector in building one.
DR. MC DONALD: Maybe the private sector can't either.
DR. FITZMAURICE: I know the government can't.
MR. MAYES: But you are acting as if there is a model. There, as you just said, there are multiple models. Some are not actually meant to be implemented in a physical sense.
DR. MC DONALD: That is the other issue. We don't --
MR. MAYES: We don't implement an information model necessarily.
DR. FITZMAURICE: But part of the problem I have is always trying to describe what we are doing in health informatics without being able to refer to a model of something.
DR. MC DONALD: Mike, the challenge is what we are trying to do and it might be a little bit like the Whitehead and Russell thing, where they are building a prints of a Mathematica and they are going to build all of Mathematica in five axioms and after ten years, someone proved it can't be done..
So, I am not positive until we see an existence proof -- I mean, I don't want -- I believe it can be done, but we haven't -- no one has got it in the whole world. MEDIC(?) started doing this in 1986. So, it is hard. So that it is -- we can't believe we have been a success until we have done it. There is too high a bar.
But I think the way to say it is the government should participate in the model development that is ongoing.
DR. FITZMAURICE: Should it subsidize?
DR. MC DONALD: Yes, that, too.
DR. FERRANS: Actually one of the things about the GCPR is that it is supposed to be able to map to the rim. I mean, that is actually one of the criteria of their models. So, in fact, it is supportive of --
DR. MC DONALD: Yes. Well, I was just trying to get it. If we just reinforce the thing that is -- it is a private sector activity or private standard sector activity the government ought to participate in --
DR. FITZMAURICE: Does it need to be coordinated? Are we wasting resources by having so many different models?
DR. MC DONALD: Yes. Well, it is sort of like -- it is like having a dictatorship or a democracy. There are obvious efficiencies in a dictatorship.
MR. BLAIR: Is there a middle ground between dictatorship and no structure at all? Because I think that a lot of folks felt that coordination was a middle ground, but do you feel like that is not true?
DR. MC DONALD: Well, having lived through a war of trying to coordinate, I can tell you a lot, but I don't know if you want to hear that. You can't make people do what they don't want to do in America, not anywhere. I don't know who is going to be the boss. You know, if you had the right -- who is going to be the king? The market forces is what we like to be the king.
DR. YASNOFF: This is Bill Yasnoff.
Can we simplify this? This is 8A. Part of the problem is that there are three different things here. I think we can agree on several of them. 8A has three recommendations. One is the government should participate in an accredited standards organization and consortia. I think everybody agrees on that.
PARTICIPANT: Yes.
DR. YASNOFF: Okay. Done.
PARTICIPANT: Good.
DR. YASNOFF: The second thing is the government should make DOD, VA and public health and other models available.
That is really a non-recommendation because anything the government develops is public domain anyway. So, we can safely recommend that, I think.
Then it says promoting harmonization of a shared information model. Now, the implication here is
-- I am not sure there is a recommendation or the thought is that if the government does these things, that will be the result.
DR. FERRANS: That is actually true.
DR. YASNOFF: But if the implication is that the government does these things, that will be the result, we can cross it out. If there is some other recommendation for promoting harmonization of a shared information model by doing some specific action, let's say what it is and see if we can agree on it.
MR. BLAIR: At this point, Bob Mayes has a comment.
MR. MAYES: I just wanted to make a clarification or something that we might want to think about in the wording when we say the government should participate or should do this. There are substantial budget implications for agencies and we are struggling mightily right now with the fact that not a dime has been appropriated for HIPAA standards that have been approved. I believe that if you are going to make the recommendation, you need to address somewhere in this document that when you say the government should, what you are implying is that it is -- it should be -- you know, it is a strategic activity that that should be funded within their budgets to do this because just saying they should -- we all agree we should --
MR. BLAIR: Is that a fourth item that needs to be added to this?
MR. MAYES: I think it covers a bunch of these things. I just wanted to mention that.
DR. FERRANS: I think it needs to be starred as a legislative proposal and that there needs to be specific appropriations.
MR. BLAIR: That would be a good legislative proposal.
DR. YASNOFF: That would strengthen this recommendation and I agree that that is certainly a problem.
MR. BLAIR: Let's get back to what Bill was taking us through. The third item is do we agree or disagree with the third item?
Could you repeat that?
DR. YASNOFF: The third part is it says "and promoting harmonization of a shared information model." That is not really a recommendation. And if it wants to be a recommendation, there -- it is either one of two things. If it is a recommendation, it is not clear. If it is thought to be a consequence of the above two things, then it should be said and in consequence --
DR. FERRANS: There is a strong business case to have a shared federal health care information model for DOD, VA and the Indian Health Service, which is why the GCPR is there. And I think it is appropriate for us to at least reinforce that. Taking that away and saying that this is a federal activity, there is a presidential directive that actually is behind that.
DR. MC DONALD: Could I suggest a compromise on that first -- we might get everybody happy or maybe not. We say the government should participate in an accredited standard development organization and promote the harmonization of a shared information model.
[Multiple discussions.]
DR. YASNOFF: What does that mean, Clem?
DR. MC DONALD: That means that it is in the context of the participation of the standards development organizations rather than on their own.
DR. YASNOFF: But is what you mean to say the government should promote the harmonization of a shared information model by participating in --
DR. MC DONALD: No, no, no. They should participate. That is clear. That is a separate bullet. They shall promote -- actually, they should promote the use of a shared information model.
PARTICIPANT: Yes, they should support it.
DR. YASNOFF: By just being there and talking.
DR. MC DONALD: It will make everybody happy, I think.
DR. YASNOFF: What does it mean, though? I am not sure specifically what that means.
DR. MC DONALD: I am not either, but it is not evil.
DR. YASNOFF: No, but I am not sure it is meaningful either.
DR. FITZMAURICE: Clem, what I would want us to mean by it is that the Federal Government should fund, as well as the private sector should fund, the development of a shared information model. It can be built in the private sector.
DR. MC DONALD: Well, maybe what might be safest is to take out that last -- what Bill was calling the last bullet and find a place to talk about models, where we can do it in one coherent fashion.
DR. YASNOFF: In the interest of moving on, why don't we note that we need to mention the issue of shared information models because the rest of this --
PARTICIPANT: At least that point everyone seems to agree on.
DR. YASNOFF: Richard, your point about GCPR, I wasn't trying to disagree with that, but if you want to say that, that should be said separately, that GCPR -- appropriation should be provided to continue GCPR's fine work in promoting a shared information model. That is fine. But that is not what it says here.
DR. COHN: Can I make a comment also about the shared information model? I am actually wondering if that may in some way be related to that Item 4, where we were talking about various activities and harmonization and this, that and whatever. We may just want to keep that as a thought.
Marjorie.
MS. GREENBERG: I don't know if anyone wants to say anything more about the shared information model. I want to say something about the old B, which is that the government should require use of accredited message format and medical terminology standards by government agencies involved in collection and dissemination of health care information. I think that is a little broad.
That would mean survey data, maps. I think it goes beyond -- that really goes beyond the scope the way it is stated.
MR. BLAIR: The word "require" is too strong? What about "encourage" or --
DR. MC DONALD: Because of data sets?
DR. FITZMAURICE: Because of things other than clinical care and it might transfer two variables out of 25. You have to put those two variables in a common format.
DR. MC DONALD: See, that is not correct. I mean, that is -- our big overall goal is to try to get people all talking from the same catalog of questions or variables or whatever. It is not a flat data set we are talking about in any of these things. What is wrong with this? If when you start to look at it, you will find all kinds of places where there is overlap and we could say "encourage" instead of "required" or --
MS. GREENBERG: Are you going beyond patient medical record information, which is what you are supposed to be doing a report on and talking about household survey data and --
PARTICIPANT: You just want to change it to patient medical record information?
DR. MC DONALD: No, no. It is whatever the capital "B" is. Whatever it was in B, I mean, in the HIPAA -- what was quoted in the beginning.
MS. GREENBERG: What you are talking about is patient medical record information.
DR. MC DONALD: It is not purely -- is this purely patient --
[Multiple discussions.]
MR. BLAIR: And Bob Mayes, you were going to suggest?
MR. MAYES: I just -- and Margaret is changing -- just take out health care information and make it PMRI, patient medical records information.
I have a little problem with government should participate in the word -- the problem I have is with the word "accredited." There are, again -- what do you mean by that? ANSI accredited? I mean, there are a number of legitimate standards organizations, OMG, I think, comes to mind, that are not accredited, per se. W3C is not accredited. Now, those are beyond and broader than some of these, but --
DR. COHN: Well, how would you interpret D then?
MR. MAYES: Well, that is, again - you know, I did that to the fact that by just talking message format, I think it is actually content more than the envelope format that we are interested in making sure they use.
DR. MC DONALD: But we didn't finish with Marjorie's point, did we?
MR. MAYES: Well, I think --
[Multiple discussions.]
-- if we limited it to patient medical record information.
PARTICIPANT: Right. We changed health care information to patient medical record information.
DR. MC DONALD: Marjorie, are you okay with that?
MS. GREENBERG: Yes.
DR. MC DONALD: Okay. Now, you want to say they should participate in all development organizations.
DR. COHN: Not all, not none.
DR. MC DONALD: I think this doesn't say you can't participate in other ones. It says but you should participate in the accredited ones.
MR. MAYES: Well, then I think you definitely have to take out the word "accredited" and "message format," since you pointed out earlier, Clem, that not all -- for instance, at the moment, X12 is not an accredited message format.
[Multiple discussions.]
It is not -- it is not an ASN.
MR. ZUBELDIA: The law actually defines standard setting organizations. It doesn't say any other wording, standard setting organizations. So, for instance, you say that, standing setting organizations, then there is already a definition on the table. Then you are safe.
DR. MC DONALD: X12 is an accredited standards development organization.
MR. MAYES: But the message -- I am going down to D, where it says government should require the use of accredited message formats. Would that be different?
DR. MC DONALD: Well, then why don't we say it message formats from accredited SDOs?
MR. ZUBELDIA: I would say standard message formats and that could also include standards by the Secretary that are not SDOs.
DR. MC DONALD: I am sorry? It could also what?
MR. ZUBELDIA: Well, the standards adopted by the Secretary, other than SDOs, but standards developed under HIPAA, for instance, security, privacy.
DR. MC DONALD: But if you open it all up, you are back to the government just making up stuff. I hate to say it that way.
MR. MAYES: Well, I mean, the government made up the NPI that has turned out to be a --
DR. MC DONALD: Oh, the government makes up a lot of good stuff, but not everything.
MR. MAYES: Right, but if you limit the ability to use anything that the government might develop, I think you are making a big mistake.
DR. MC DONALD: No, I am not trying to limit it. I am trying to -- the thrust of HIPAA was that the private standards organizations have -- HCFA just doesn't do what it feels like tomorrow and that becomes a standard. That is --
DR. COHN: Clem, that is right and there is a whole NPRM process, but be aware that in the legislation there are provisions that the Secretary can develop their own standard if the others are found wanting. So, I mean, there is that capability.
I guess I am just sort of -- standard message
-- government shall require use of standard message formats and medical terminologies. I guess I am having trouble with what "standard" means, but it is probably -- HIPAA mandated standards or which standards are we talking about?
MR. BLAIR: Again, at this stage, I think we are close enough for concept work and -- is there any other conceptual or major problem with this point? If not, then lets go on --
MR. ZUBELDIA: I think that entire sentence could be translated as eat your own dog food.
MR. BLAIR: Eat your own dog food. We will capture that one.
Margaret, I think we can go on to our next item.
DR. COHN: What number are we up to now?
MR. BLAIR: I think it was 8.
MS. AMATAYARUL: Yes, I am sorry. My numbers keep shifting on me here, but the next one is clinicians are essential to the process -- did I skip one?
PARTICIPANT: No.
MS. AMATAYARUL: Clinicians are essential to the process of verifying the appropriateness of PMRI standards against clinical processes, work flow, data capture, data content and structure and identifying key elements data sets required for sharing data. And the recommendation is the government should provide incentives to encourage the professional societies to support clinician participation in PMRI standards development.
DR. YASNOFF: What does this mean? What does that mean? I am the Secretary. You are briefing me. What does that mean? What am I supposed to do?
MR. BLAIR: I think it is a first step. You know, I think that we would have to add flesh to the bones. I think she just wants to get -- is there agreement on what -- just what she said so far and then we could wind up deciding, you know --
DR. YASNOFF: Well, it depends. It depends on what the incentives are. I mean, you know, if the incentives are, you know, monthly trips to Hawaii, I don't think I agree with that.
MR. BLAIR: Right. And I don't know that she intended to have us go down to the explicit level of exactly -- Margaret, I don't want to answer for you. Is there any elaboration that you had based on, you know, how you came up with that particular recommendation?
DR. FITZMAURICE: Why don't we hear from Kathleen and from me first and that gives Margaret more to respond to -- and Bob.
MS. FYFFE: I don't think the government should provide any incentives or even get into that ball game at all with professional societies. If they are interested, they will participate. If they are not, tough luck.
DR. FITZMAURICE: I want to support what Kathleen said, that if they don't have sufficient incentives to participate, then --
MS. FYFFE: They are professionals. They are supposed to be --
DR. FITZMAURICE: -- then why should the government pay them.
MR. BLAIR: Is that the consensus of the group?
MR. MAYES: And actually it shouldn't be limited to -- why just clinicians?
DR. FITZMAURICE: I can see bringing in experts and paying experts for particular parts of standards, but as a professional society, you should be interested. You should be involved and the case should be clear to you that you should participate and if it is not, then you won't.
MR. MAYES: I think I hear a consensus --
DR. COHN: Can I make a comment? Actually I think that this is sort of one of those guiding principles.
DR. MC DONALD: Can I try another word?
MS. FYFFE: Okay.
DR. MC DONALD: Would it be all right if we just said the government should encourage professional societies to support. Leave out the incentives.
MS. FYFFE: Why should they encourage them?
DR. MC DONALD: What does it cost to encourage?
DR. FITZMAURICE: Here is the reason.
MS. FYFFE: All right. Give me the reason.
DR. YASNOFF: Let me just -- this is Bill Yasnoff -- the reason to encourage it is because, as we have said before, some of the activities related to standards are involved activities, where the practitioners may have to take on a little bit more burden for the good of society over all and if that is the case, then they have a disincentive to participate in that and maybe we do need to do something. I don't know. I am just trying to state the --
DR. COHN: Well, can I just make a comment here because I am just sort of wondering, wouldn't this be something that you would use to help evaluate whether you would be recommending the standard, the quality and its ability to do all of this and, therefore, it is the sort of thing that would be a guiding principle around, you know, did somebody evaluate the appropriateness or was there clinical input into this, X, Y and Z, as opposed to this issue of encouragement specifically? I mean, it is more of an issue of expectation, I would expect.
DR. FITZMAURICE: One could also say this might be part of national leadership on the part of the government to say we are leading this effort. We encourage you to participate in it because it is necessary for the efficient operation of the health system and to improve quality. I can see that case being made.
DR. MC DONALD: It will bring it -- there will be more focused -- they are more likely to think about doing it if someone like the government says think about doing it.
DR. FERRANS: Well, let me just make other point is that especially in the areas of medical terminology, this is certainly going to be subject matter, expert intensive. Now, if we can't -- put it to you this way, we can't under -- you know, if we -- and there has been talk about underwriting terminologies and government support for that. In some ways, if -- and the reason I bring this up and it is a related issue is that if we decide that there should be government support or subsidies for terminologies, that part of those monies actually go to get the subject matter experts involved.
It would have some sort of passer effect, but if not, are you specifically saying in order to accelerate development, we need to pay people to be away from seeing patients because otherwise it becomes a charitable event for them and limits their participation, which slows down the development and refinement of standards.
MR. MAYES: When we talk in the other terms about providing subsidies, that is to organizations. I don't have a problem providing subsidies to organizations. If they want to work up some process to get expert involvement, that is fine. I don't see how we could justify supporting individuals -- well, we could. We have the European model. We can simply pay individuals to be experts, national experts, and we will soon form a cadre of people -- if you have ever been to an ISO meeting, you will find out exactly what we will wind up --
DR. FERRANS: Well, I am not suggesting that we do it, but I am saying that is really sort of what we are talking about and the money would go to societies.
MR. BLAIR: I just heard Kathleen -- are you saying that if they have the word "encourage" in there that you would accept that?
MS. FYFFE: I defer to the docs.
DR. MC DONALD: I can't put my hand up, so I just -- but I just think that we should be paying them and I am a doc and encourage doesn't cost anything. We should encourage them and you should see the ISO process and all these professional standards guys and it isn't the best way.
DR. COHN: So, you like "encourage," right, Clem?
DR. MC DONALD: Yes.
MR. BLAIR: Does this leave us in a position where we could move on to the next item?
DR. COHN: Yes.
MS. AMATAYARUL: No. 10 is many testifiers felt a lack of conformance testing of message format standards by an independent agent was a barrier to full deployment of health care information systems. The recommendations include, first, the government should adopt guiding principles for PMRI message format standards that include the requirement for conformance testing so that they have sufficient detail, clarity and precision to facilitate interoperability. And, second, the government should designate and fund start up for an independent agency or agencies; example, NIST, Association for Health Care Transactions, others, to design and execute conformance testing of PMRI standards.
MR. BLAIR: Could we take these one at a time, please? And comments on the first recommendation about the guiding principles -- is there any argument about the guiding principles?
DR. MC DONALD: Just wordsmithing, but I will delay that. I think it is a perfectly good idea.
MR. BLAIR: Okay. So, then the next item --
MR. ZUBELDIA: Jeff, this is Kepa.
I will go back to the comment that I made earlier. I don't think the government should have guiding principles. I think the government should adopt message format standards that include the requirement and have the standard or the standard implementation guide that includes that requirement. The guiding principle is what --
DR. COHN: The HIPAA -- actually, I am going to agree with you on that one. I think that this is really actually part of Item No. 1, which is sort of right underneath implementation guides. This is -- you have implementation guides and then you have conformance testing to, once again, ensuring interoperabilities. So, I think it is just sort of a sub-point of that.
I agree with you. I don't think it is a guiding principle.
MR. BLAIR: Okay. So, Margaret, were you able to capture Kepa's wordsmithing and also Simon's point of moving this up under Item 1?
MS. AMATAYARUL: Yes.
DR. MC DONALD: Wait a minute. What does that mean? Does that mean it doesn't have its own bullet?
MR. BLAIR: Well, there was a previous bullet under 1. I don't know that -- I think this was before you joined us, where Simon had pointed out that the idea of implementation guides and conformance testing were very closely related under Item 1. So, Simon was suggesting that they be grouped together.
DR. MC DONALD: Does that work for you, Kepa?
MR. ZUBELDIA: Yes, that is fine.
DR. MC DONALD: But the thing is this -- they are not the same and this has been so underdone that I love having it as a separate bullet. It has been so underattended to. That is half the problem.
MR. ZUBELDIA: But we are also expanding No. 1 to double up No. 2. So, we have No. 1, No. 2 and No. 10, basically one and the same.
DR. MC DONALD: Well, I guess, I would lean on the side of leaving it a separate bullet because it -- people might object to it, too, but we ought to --
MR. MAYES: Can we just agree that the points are related and not figure out how many bullets there should be or how they should be divided at this point?
MR. BLAIR: Okay? Then the other piece is the third piece of that was Margaret had apparently gathered together some recommendations for how this be done. Do we need to reread that again or -- but let's get our comments on whether that is appropriate or not. I think NIST was in there and --
MS. AMATAYARUL: The government should designate and fund start up for an independent agency or agency; for example, NIST, Association for Health Care Transactions, others, to design and execute conformance testing of PMRI standards.
MR. ZUBELDIA: Margaret, my first comment on that, it is not the Association for Health Care Transactions that is doing that for the X12 standards. It is EHNAC, Electronic Health Care Network Accreditation Commission.
DR. MC DONALD: I am sorry. Did you say they are a good candidate or a bad candidate?
MR. ZUBELDIA: No. They are currently doing that for X12 standards on their HIPAA. They are performing the compliance verification system. It is available on the Internet. You can send an X12 transaction to EHNAC and they will tell you whether it complies with implementation guide or not.
MS. FYFFE: EHNAC?
MR. ZUBELDIA: E-H -- Electronic Health Care Network Accreditation Commission, EHNAC.
DR. MC DONALD: That is a different one that is not listed here?
MR. ZUBELDIA: That is correct.
MS. AMATAYARUL: EHNAC?
MR. ZUBELDIA: NAC.
DR. MC DONALD: Well, I was going to bring up
that the risk of putting specific names in here is that you will never get everybody happy.
MR. BLAIR: Well, it is just an "e.g." It is just a "such as."
MR. ZUBELDIA: And effect is not involved in that at all.
MS. GREENBERG: Is there an AHCP?
MR. ZUBELDIA: No, no. The acronym is AFEHCP.
MS. GREENBERG: Okay. This is not --
MS. AMATAYARUL: This is a different group.
DR. MC DONALD: Well, could I just -- I don't think that which list -- we are not proposing a specific one. Maybe we should just take all of them out so that we don't get everybody stirred up about who is not there. Or else would it be safest to leave in just NIST?
MS. FYFFE: No, I don't even want NIST in there.
DR. MC DONALD: No one disagrees with this. It is just a question of what will work better. I don't care whether you put four of them in or one of them or none of them in.
DR. COHN: A real quick question just in terms of the model of how this works for X12. Did the government designate and fund start-up?
MR. ZUBELDIA: No. This is an initiative of EHNAC and it is paid for by subscription. You buy a subscription. I think it is for like $450 and you can send 300 tests or 600 tests, something like that. So, there is a yearly subscription fee. It is a very large number of tests, where each test is a dollar, a dollar fifty, something like that.
MS. FYFFE: Let me just -- one important wordsmith here. Government should designate and fund start-up for an independent agency or organizations.
DR. FITZMAURICE: And I would strike "independent" and put "independence" after "to design," to independently design and execute conformance testing.
We don't want to create another government agency.
MS. FYFFE: That is correct. Good, Michael.
MR. BLAIR: I am pausing because I don't know how much time Margaret needs to --
MS. AMATAYARUL: Keep going, Jeff.
MR. BLAIR: Then I would ask you to go to the next point because I think that --
MS. AMATAYARUL: Okay. No. 11 is most testifiers viewed the development of message format and medical terminology standards as needed to be kept in the private sector in order to be more responsive to market needs. The recommendation is in order to encourage private sector contributions, standards developers should be encouraged to adopt a formal government -- I am sorry -- a formal process of recognizing these contributions and protecting proprietary interests and intellectual property.
The question we had was what should the government's role be?
DR. MC DONALD: I have another question. Why would we want to have this one?
PARTICIPANT: What does that mean?
DR. MC DONALD: I mean, we are -- being in the private sector -- these are not -- they are not connected. I mean, the standards organizations and the private sector might be -- have no cost licenses.
DR. FITZMAURICE: This might better be handled in a section called "Role of the Government," where we talk about what can be handled in the private sector and what can be handled in the government, rather than as a specific recommendation.
MS. FYFFE: Let me make a comment here. This is -- is this -- question, actually -- is this the fear that some of the testifiers expressed that, you know, they didn't want to waste their time and money and lose market share? I mean, they wanted protection? I hate to be that blunt about it, but --
DR. FITZMAURICE: I don't think they said it just that way, but the implication --
MS. FYFFE: Well, that is what they meant and I don't know that we even want to mention this.
MS. AMATAYARUL: There were several testifiers, who applauded some of the efforts by some of the standards groups to allow contributions to be anonymous so that they encouraged more contributions. Some testifiers suggested that there be a way to do that so that vendors would feel more comfortable sharing proprietary information.
DR. MC DONALD: Could I just make a -- No. 11 as an issue, I think, is well-stated and is good and right, but I don't think the answer has to do with that. The commercial vendors participate in these standards groups all the time and it works just fine. I don't know -- I don't see -- I didn't hear -- well, I am misunderstanding why there is a problem, except to say that the recommendation would be that we do encourage keeping it in the private sector.
MR. BLAIR: At this stage, I think the key question is -- it was pointed out -- and Margaret, you know, considered this important enough to get this, you know, on the docket here, but it wasn't clear what the government role should be.
If there is no one that has a suggestion for what the government role should be, then my suggestion is we delete it.
PARTICIPANT: I agree.
DR. COHN: Yes, I think I would agree on that.
DR. MC DONALD: Well, but, Jeff, the statement that the people believe it should stay in the private sector and not become a government activity, we are going to lose if we don't have some statement like that.
MR. BLAIR: Well, Clem, we already have it captured up in the introduction pieces, in the general rationale?
DR. MC DONALD: All right.
DR. FITZMAURICE: That is where I think it should go.
MR. ZUBELDIA: We can also report the issue and just state it as a statement, without having to make a recommendation about it.
MR. MAYES: Just agree with it.
MR. BLAIR: Margaret, I think we can go on to our next --
DR. COHN: Actually, could I just ask a final question about this one because I understand 9, the issue. I am still mulling -- are we just completely going to get rid of the recommendation or are we going to state it somewhere else? I am saying I hope not.
MR. ZUBELDIA: No, Simon. It is already in the introduction under "General Rationale."
DR. COHN: Okay. Because the recommendation is very different than what we are talking about. The issue brought up is that these things should be kept in the private sector. The recommendation seems to have something to do with acknowledging contributions, protecting proprietary interests and intellectual property, which I sort of read as a whole other issue that I don't want to see there.
MS. AMATAYARUL: We have deleted the recommendation.
DR. COHN: Okay. I just wanted to make sure that that was not being referenced in any way, shape or form.
MR. BLAIR: That is correct.
DR. COHN: Thank you.
MS. AMATAYARUL: The next issue and recommendation is in the "Medical Terminology Section."
MR. BLAIR: Let's take a break at this point.
Are we taking a break? Okay. Can we get back in ten minutes? Is that good enough?
[Brief recess.]
Agenda Item: Development of Recommendations for Medical Technologies
MR. BLAIR: Can we begin with medical terminologies?
MS. AMATAYARUL: No. 12 is many testifiers indicated that most terminologies today do not incorporate the characteristics and attributes that are necessary for clinicians to have confidence in them and rely upon them for clinical use and accepted as national standards.
The recommendation is the government should adopt guiding principles for PMRI medical terminology standards that require characteristics and attributes for clinical specificity and comparability. For example, comprehensiveness, coherency, non-redundancy, mappability, lexicol rules, context, pre-identifiers, version control, coordination, et cetera, necessary for them to become national medical terminology standards.
MR. BLAIR: May we have comments or critiques on this very first important point because this point pretty much sets the framework for a lot of the other issues that Margaret has listed.
Bob Mayes.
MR. MAYES: You know, I guess we are starting off all of these that the government should adopt certain guiding principles. I mean, it gets back to Kepa's comment earlier about whether that -- what does that mean, the government should adopt guiding principles? Where should it adopt it?
I am not quite sure that that is necessarily actionable or it is not described in a way that makes much such to me.
MR. ZUBELDIA: This one is probably the only one where I think there is a possibility to adopt guiding principles to let the standards setting organizations define their own terminologies following certain principles.
MR. MAYES: Do they promulgate those principles? I am not sure --
MR. ZUBELDIA: -- to the industry because I don't think we are ready to adopt standards yet.
MR. MAYES: If we change the word from "adopt" to "promulgate," then I think it means that the government is going to do something.
MR. ZUBELDIA: Define.
MR. MAYES: Define, whatever.
MR. BLAIR: What is your modification of your wording on this one, Kepa?
MR. ZUBELDIA: Instead of adopt guiding principles, the government maybe should promulgate guiding principles or should define guiding principles for the standards and then let the standard setting organizations define the standards.
DR. COHN: Which standards organizations?
[Multiple discussions.]
No, but I am saying is this the medical terminology standards organizations determine it or the message format standards organizations?
MR. BLAIR: No. We are on medical terminologies.
DR. COHN: So, what you are saying is is that the government should provide direction by these guiding principles. Is that what you are saying?
I mean, we have guiding principles around. It is easy enough to put up a list of them.
MR. BLAIR: My thought behind this one is that the government role should be stronger in this because we have already had a lot of work with these particular characteristics and attributes. I mean, it has gone through years from beginning with the testimony we received from Jim Simino(?) on the -- I forget his words. In any event, he pretty much had these and then Dr. Cohn and Chris Shute(?) came up with a framework that CPRI and ANSI HISB supported and that extended them some more and now we wound up having an ASTM standard by Peter Elkin(?) of the Mayo Clinic, that he led, which took it further into a specification.
So, I think that there has been repeated endorsements and enhancements of these characteristics and attributes for medical terminologies to make them comparable and interoperable. I would think that if we don't say that the government should adopt these as guiding principles, I think we ought to be strong enough to say that they recognize them.
Okay? That is my story and I am sticking with it.
MR. MAYES: Would you then consider as an action item something analogous to that that we had under conformance testing, that there would be -- I give as an example, the American Nurses Association that actually has a set of formal criteria that they are now applying to any organization, which is to submit their code sets, data sets or terminologies and then they get sort of a seal of, yes, it meets these criteria. It is an ANA-recognized whatever.
That is -- as a model, would you suggest that that would be a role the government would play or this independent conformance agency could play?
MR. BLAIR: My thought on this one -- because the ANA is also winding up being consistent with the other ones that I referenced as well. So, there seems to be a lot of convergence on the same characteristics and attributes -- my thought on this was that this was a foundation because later on we might be called upon to acknowledge or adopt a particular terminology or recognize it or provide funding for it or subsidies for it.
So, it was to reference back that these would be the characteristics and attributes that would be the criteria for any other action that the government does, whether it is subsidies or incentives or anything else. That was the way I was thinking of it, but maybe you want to do something different.
DR. COHN: I guess I am seeing -- I think that something like this is very useful and relatively important and I think we can actually -- once again, it isn't something that the government has to develop these principles. It is more, once again, adopt -- I mean, I think there enough principles out there that Margaret could pretty quickly print us up a list with definitions. I mean, not here, but by January.
I am still struck with exactly how we are going to use it because I can't think of very many, if any, terminologies that have all of these characteristics. It is more in most cases an idealized set.
I am well aware that things such as usability, support evidence-based medicine, da, da, da, da, da, typically isn't in these lists. And one would certainly want to probably include some additional -- I mean, as something that meet all these attributes, but not be useful or usable is probably missing the point a little bit.
MR. BLAIR: I will tell you what, could we go on -- because there is going to be another item that we hit that refers -- at least one, if not two or three others items that we hit that refers back to this Item No. 1 as the criteria for further government action.
MR. MAYES: Can I just make one comment, just one?
Maybe the approach is something analogous to what we did with the HIPAA security standard, which was actually more of a performance guidance standard versus a specification for a specific implementation. And sort of treat these criteria along those lines, saying something like, you know, in order -- and it gets back to what you are saying, Jeff -- in order for a standard to be eligible for -- or vocabulary to be eligible for further action, you know, whether it is subsidy, whatever or whatever, you know, here are the sort of levels of performance that you should try to meet in developing a standard and you should be able to document to what level does your vocabulary actually meet these criteria.
DR. COHN: So, it isn't an all or nothing thing?
MR. MAYES: No, it is not an all or nothing. It is just sort of here -- you know, here is a bar that you can -- here is a performance bar that you can sort of use as a judge and it is actually multiple bars because it is multiple criteria. It is not a sum game.
MR. ZUBELDIA: The problem then becomes interoperability.
PARTICIPANT: But I help promote this interoperability with these characteristics.
MR. ZUBELDIA: I agree. I mean, if you have the criteria of guiding principles for the development of multiple terminologies and there is tens or hundreds of them. You don't have an interoperability.
MR. MAYES: Well, but, Kepa, I don't really know whether or not we are ever going to get to a single terminology. I think terminologies are to some extent quite context specific. If that is the case, it is not so much that you would have multiple terminologies within a particular context.
MR. ZUBELDIA: But by conducting those guiding principles, you are going to have terminologies that have been developed correctly.
MR. MAYES: Yes, which may not inter -- may not map.
MR. ZUBELDIA: May not map, but they have been developed correctly.
MR. BLAIR: Actually, Kepa, Simon made the point. It was quite accurate that there is not a single terminology out there that meets all of these. This was -- I thought the word "guiding principles" or "framework" is very appropriate because what these are is these are targets. These are goals that maybe five or ten years from now some of the terminology developers will finally achieve, but all of these are things that are characteristics and attributes that are necessary not only interoperability but for clinical specificity, for comparability, for data integrity.
So, they are good characteristics that are good targets and it would give a lot of latitude because if we wind up saying that these are the basic characteristics that are needed, that a lot of other decisions that we are going to look upon in the rest of this list, it is -- we could refer back to these as saying, you know, that these are the criteria or guidance that the government could use in terms of whether it provides an incentive or subsidy or whatever.
MR. MAYES: Could I actually expand on that, Jeff? This is Bob again.
Maybe what we are actually looking at -- and this sort of goes to where I think Peter Elkins' work has been focused, is trying to develop a set of metrics really that you can apply. More than just guiding principles, can you define some metrics that you can apply to do a more critical analysis of these very important issues and how they relate to interoperability.
Again, it -- these are not specific enough necessarily. They are areas, but if you could define "metrics" within these areas, mappability being one of them, for instance, you would then be able to do a lot more analysis as to exactly where are the issues in terms of interoperability. I don't know. I don't follow Peter's work quite in depth enough, but I know that Peter -- that is an area that he has been interested in is trying to define things in a measurable way.
DR. COHN: Margaret A. had her hand up.
MS. AMATAYARUL: Simon, I have a question for you. You had commented that I should perhaps list all the criteria and attributes that have been identified for the purpose of the report. Do you want me to do that or do you want me to reference the proposed standard or --
DR. COHN: I think we ought to take a look at the standard. I mean, I am, obviously, familiar with the framework, which I was one of the authors on. I am not familiar with the ASTM standard. But it sounds like something we ought to get a copy of and review between now and soon and sort of figure out what is the best way to handle that.
MS. AMATAYARUL: Okay. Do you want me to send you a copy?
DR. COHN: Yes, if you have one?
MS. AMATAYARUL: I don't have one electronically but I can probably get one from Peter, too.
DR. COHN: Yes, I can also handle just regular mail. Probably other members of the work group would like it, also, I presume.
MS. GREENBERG: Developing a standard --
DR. COHN: ASTM is developing a standard, which I -- I don't know the specifics of.
MR. MAYES: I think they referred to it as indicators. So, it is a standard specification of indicators and in their case they wound up focusing on health care quality, to promote health care quality. So, you know, you could look at it from many different perspectives, but you look down those characteristics and you see essentially the same thing that Simon and Chris and Jim Simino, over the years, they have all wound up, you know, basically saying the same thing.
DR. FITZMAURICE: So, could you run it by again? What is the government action that we are recommending on this?
MR. BLAIR: Margaret has that --
MS. AMATAYARUL: The government should promulgate or recognize guiding principles for PMRI medical terminology standards that require characteristics --
MR. MAYES: Mike, the idea was that that would form the basis for any other action the government might take, such, in terms of subsidies or --
DR. FITZMAURICE: Is it a desiderata?
MR. MAYES: Yes. Thank you. It was the desiderata. It was Simon's and Chris's framework document and that has now evolved most recently into an ASTM standard indicators.
DR. FITZMAURICE: I am not sure promulgate is right. Maybe set out? We will move on.
MR. MAYES: It was initially "adopt." And we didn't think that was the right word.
DR. FERRANS: Well, it has been an orphan.
DR. FITZMAURICE: Yes, I would probably not have "promulgate." I think you have got another word in there already, which is sufficient.
MS. AMATAYARUL: "Recognize."
DR. FITZMAURICE: "Recognize," I think, is sufficient.
PARTICIPANT: How about "utilize"?
DR. FITZMAURICE: Do they already exist so the government does not have to develop them?
DR. COHN: Yes.
DR. FITZMAURICE: We should then point to the place where they exist.
MR. BLAIR: Well, that was what Margaret was asking and -- go ahead.
MR. MAYES: Maybe the word should be "utilize." The government should utilize these if it is to inform the basis --
[Multiple discussions.]
PARTICIPANT: What is wrong with "adopt"?
MR. MAYES: How do you adopt the guiding principles?
MR. BLAIR: I will tell you what. We can work that out later. Just, you know, recognize, adopt, whatever.
MS. AMATAYARUL: No. 13, virtually all testifiers indicated a need for a solution that allows message format standards developers, vendors and other users to reference and use medical terminologies that is equitable to all users where their adoption in health care information systems will be constrained. The specific issues include pricing, access, cost and licensing of these terminologies.
The recommendations include to ease the financial burden expressed by developers, vendors and users of medical terminologies. The government should subsidize medical terminology developers if they meet the following criteria: (1) provide critical coverage of one or more medical domains; (2) meet the characteristics and attributes for clinical specificity and comparability of data and (3) provide access to a terminology server that archives versions, supplies, changes, et cetera.
DR. YASNOFF: Can we stop and discuss them?
DR. COHN: Why don't we read the whole thing and then we can go back and discuss each piece?
MR. BLAIR: Want to read them all and go back?
DR. COHN: Yes, I would like that.
MS. AMATAYARUL: Read them all?
DR. COHN: Yes.
MS. AMATAYARUL: B is the government should provide some measure of regulation and audit of medical terminology developers, who receive government subsidies. This note was kind of just in explanation. As with charity organizations, ,where investment int he charity may not translate into actual value for the intended target of the charity, some measure of regulation and audit by government is necessary to protect the investments of government payers, providers and vendors in the resulting standard.
C, the private sector should support the development of medical terminologies, but to reduce the cost burden to vendors and users, the government should provide incentives for the users to implement medical terminologies, possibly through paying on the margin for comparable data.
D, the government should clarify the legal relationships between the contributors to the UMO as in the user's fee, UMLS, so there is an unequivocal understanding of what the users may or may not do and what the contributors may and may not demand.
DR. COHN: Can we start off at the beginning? I think Bill had a comment about the first one.
DR. YASNOFF: I think the issues here -- there are a couple of different issues. If the government adopts and/or subsidizes a particular medical terminology, the result is likely to be a monopoly by that terminology. So, there has to be some counterbalancing force to deal with that. There are several ways to approach it, but this, again, B, the government should provide some measure of regulation and audit, is attempting to get at that and, as usual, I would like to see it be more specific.
One way to get at that is to say to a terminology developer, we, the government, want to use your terminology in the government and because that will make you a standard, if we do that, then we will pay you x amount of money, but then we expect you to not charge anybody else more than y. Effectively, price controls.
Another way of doing it is the government could demand most favored customer status, saying we will -- we the government want to use this terminology. We will pay you 3 cents per covered life per year and we expect that that is going to be the best price you give anyone. So, you know, go out and sell it for what you want, but we are going to pay the lowest price, which is we understand it is 3 cents per covered life per year.
That is another way to approach it. So, what I am advocating is some more specific recommendation with respect to how this process would work to both encourage -- to allow the government to adopt standards without having the adverse consequences in terms of cost to the rest of the users, who are then forced to buy this terminology that the government has endorsed at uncontrolled prices.
DR. COHN: Yes. Well, actually I was going to make a comment here also. In some ways, I think I am sort of agreeing with what you are saying, though, by making a couple of even broader comments. I mean, first of all, this group does have some choice about how far it decides to get into this particular issue in the sense that this is an issue that is already sort of out of the bag and deals with issues that are already beyond just clinical -- or medical criminologies. I mean, it is more of a generalizable issue to all code sets and the -- you know, and I am sure the full subcommittee, which we are, obviously, all the same group is likely to be getting into this further on in the year, sort of regardless.
So, we do have a little bit of discretion about how hard we push this one. Now, having said that, I find it sort of curious that -- it seems to me there a number of different models in how you approach these issues. I mean, one of them has to do with governments -- you know, all involved with trying to sort of reduce burdens and, et cetera, et cetera. But one of them has to do with, gee, the government is subsidizing something. Therefore, probably by some logic, probably actually ought to be free or something close to that. That is a way to exert some control. But there is an equal -- another side to this that says, gee, if you are affording an organization a monopoly in a market -- and, once again, I am remembering back to when I had a single telephone company that was a monopoly in my market or a utility that was a monopoly in my market -- I know, old concepts, but then, again, I am 50 -- that in exchange for that monopoly right, there was a submission to regulation.
I find it somewhat curious that the only view expressed here has to do with the fact that the only way that regulation would occur is if there were money that the government actually were subsidizing the organizations with. I am thinking that there is probably a couple of different approaches to this, based on the facts of the situation.
Once again, it is just a sort of a thought, but it seems to me that regardless of whether you are subsidizing or not, that there needs to be ways to assure if the government is providing a monopoly, which it is going to be doing and is in the public interest, there ought to be regulation that comes along with that.
DR. YASNOFF: I certainly agree with you that the government doesn't have to spend any money in order for this to occur. The government can just adopt a standard, you know, adopting a terminology by the government can be a de facto requirement for everyone to use it.
So, we do agree that -- you know, I am not saying necessarily that the government should subsidize these terminologies, but my assumption is that if the government wants to use a particular terminology, that they will pay something for it because they are -- the developers are entitled to some compensation. But that wouldn't necessarily -- I wouldn't necessarily put that in the category of subsidization. That is a purchase.
MR. BLAIR: Margaret?
MS. AMATAYARUL: Yes?
MR. BLAIR: Bob said that you had a question or a comment.
MS. AMATAYARUL: No. I was asking Simon to talk into the microphone because I couldn't hear him.
MR. BLAIR: Could I relate why this subsidy issue is here on the agenda is that the government is already doing that, but there is no criterias that I am aware of across the board and there is a lot of folks that were testifying where they were saying, gee, some are free and others I have to pay fees for.
They were complaining about the fees and if there is not a criteria in place for a coordinated view on this -- maybe that is Clem?
PARTICIPANT: Jackie is taking care of it.
MR. BLAIR: Okay -- then we are going to wind up continuing kind of with a lack of direction and a lack of coordination, but this is trying to, you know, put in place the fact that, you know, we have -- there is an overall design to improve interoperability and clinical specificity and all of the things that we want to have happen to improve health care. And let's apply those as criterias if any continuing subsidies go forward.
DR. FITZMAURICE: Can I interject something here? I am glad there is a private sector out there that invents things that are useful and saves some of us government bureaucrats from making mistakes that don't stand the market test.
On the other hand, I am not happy sometimes when there are monopolists out there that the price is so high that it deters their use. I would rather -- and I push for specific recommendations. In this case, I would push for a more general recommendation, one that says we ought to make sure that the terminologies have -- meet good criteria, so they should be evaluated.
We should also have them looked at for, for lack of a better term, value commensurate with their cost. What is the remedy? I don't know that I am smart enough to determine the remedy. Usually the best remedy is to develop or invent something that is a close competitor of the -- say of the terminology of the coding system of whatever and let the two duke it out in the marketplace. And part of that duking out is lowering prices.
Am I advocating two standards where one will do? Only when it is in the public good. So, I would put in here a sense of for the public good, the government should examine terminologies for the following two or three criteria. One of them is the exercise and monopoly of power. The second one is clinical excellence.
DR. MC DONALD: Is this 13B you are on? Which one?
DR. FITZMAURICE: 13, all of them, but we are specifically talking about the issue of whether the government should subsidize terminology.
MR. BLAIR: Actually, Clem may not have heard our discussion on the previous one, on the characteristics and attributes.
Did you hear that, Clem?
DR. MC DONALD: No, but I think I would agree with it, whatever you said.
DR. COHN: Good. You can comment later.
MR. BLAIR: You had a comment on this one?
DR. MC DONALD: Well, this one, I think -- I think that the medical -- the thing on the left, the issue is right on. The challenge is is finding a way to address it, which I guess you are now wrestling with. I think the idea -- well, I have an interest in subsidies in some sense. So, I should make that clear, but I think the idea of having federal funding for the public good is good. The challenge is what Mike was just saying, is how do you keep guys from ripping you off and doing a bad job?
Actually, I don't think it is a bad idea to say you are going to support a competing one if it doesn't work out right, although you will catch a lot of crap -- I mean, hassle for it.
DR. COHN: I think I am actually next in line and then Kepa and then Bill Yasnoff.
MR. BLAIR: Thank you.
DR. COHN: I was actually just going to comment. Michael was sort of mulling about whether we ought to have multiple different standards for the same thing, doing exactly the same thing, to help excite the marketplace.
DR. FITZMAURICE: Where do we find a monopolist position that is not in the public interest? What are some of our remedies? Some of them developing competing products and let them duke it out. That was a --
DR. COHN: Well, and I guess I was just someone who -- putting my hat on as we were asked to implement and actually even in databases actually use this data. I think my interest is is that we try to regulate these things in a way where that doesn't come to pass. I guess that was sort of my role in having to have two different standards for sending exactly the same sort of data. It would be, I think, much more preferable for the industry if there were ways to regulate so that you had one good standard that they could evolve and become even better.
That may not be possible but --
DR. FITZMAURICE: Simon, I can see that. I just don't know whether the government should use its heavy hand and whether the government should subsidize a competing terminology. I don't know whether it depends on the special case, whether we should say we are going to do it this way all the time.
I am just not smart enough to know at this point.
MR. ZUBELDIA: I think the role should be more like the public utilities commission to regulate what is the maximum price that can be charged for the license because with the second option that Bill mentioned, like most favored customer status, where the government contracts for a set price and that marks a low price, I think that can be conducive to reverse subsidy, where the rest of the industry has to pay a much higher price because the government is not paying enough.
That would not be a desirable situation. So, I think it is probably better to regulate within negotiated process and appropriate compensation to the developer of a terminology and everybody pays the same price, including the government.
MR. BLAIR: There is Bill, Clem and then Bob.
DR. YASNOFF: For Clem's benefit, I suggested two possible options. One is that if the government adopts a standard that they essentially by doing that set up a monopoly and, therefore, in the process of doing that, they should, of course, pay for the use of the terminology, but also insist that the terminology developer be regulated and have their prices controlled, which is what Kepa was supporting, I believe.
The other option that I was suggesting -- and I am just suggesting these as options. I am not sure which one is right or if any of them are right -- is the idea of the government paying some price, say, on a per life covered basis for using terminology and insisting they get the best price. This is a typical government purchasing strategy. I agree with you, Kepa, the possible result of that is that it is a reverse subsidy from the industry.
Mike, I think I may disagree with you on this one. I don't think that in the issue of terminologies and perhaps in standards in general, that having competitive standards has the desired effect that competition does in other markets. I just don't see that. I think about it --
DR. FITZMAURICE: -- just on mappability.
DR. YASNOFF: Yes, I just -- you know, I think of it as, you know, two different distances between the railroad tracks. I mean, it is just, yes, you could -- you know, when the different railroad tracks get together, you can have an adapter, but I think that there is a public good in having a single standard, but then -- but my concern here -- and I think other people share the concern. It is just a question of what to do about it is that in trying to serve the public good by having the government set or use a standard, then we create a problem, which is we create one or more monopolies.
MR. BLAIR: I think Clem is next.
DR. MC DONALD: I think this is a great -- 13 is a great line and I guess I sense that everyone senses that the issues -- we agree on the issues and it is just a question of what remedies are available. Is that correct?
MR. BLAIR: Yes.
DR. MC DONALD: It is a tough one and I don't think I would close off Mike's option as a threat in the recommendations because it might help to in a very efficient way regulate some of the otherwise bad parts that could happen because there are two types of monopoly. One of them is is you get lousy service and so that the price is just kept down -- you know, they may just stop developing. So, it is a tough dynamic thing and I think the threat of an -- especially if we are now talking about -- we are thinking there are really going to be a couple of -- a handful of different domains, that it may not be disastrous to think about a replacement one at sometime in the future, if the monopolist wasn't behaving.
MR. BLAIR: Bob Mayes.
MR. MAYES: I find it striking and somehow difficult to comprehend why we -- we have not entertained the idea of monopoly for any other standards that we are talking about. I don't quite understand what is so absolutely unique about terminologies that we -- I mean, the current process is, in fact, that, yes, they are being developed by some organizations as revenue generators, but, guess what, so are proprietary standards in the broader markets of computers and stuff, ala the latest court trials with Microsoft.
I mean, I don't -- why we would even contemplate generating the same kind of issue that the Justice Department has just been fighting about with Microsoft in the realm of medical terminologies is beyond me. We have examples of medical coding systems, like ICD-9, that are developed in a process that does not lead to monopoly in terms -- it leads to a single set, but it is not a monopoly in terms that someone has controlling financial interests and, in fact, can limit participation because of that.
I think we are just going down a real dangerous path here and I think if I were HL7 or some other group, I would start saying, well, wait a minute. Gosh, I am going to start charging for my standards extremely high prices or stuff like that. I don't see why something so unique to this.
MR. BLAIR: Clem and Simon and then I am next in the queue.
DR. COHN: Bob, I am actually scratching my head a little bit, only because I think that we have created monopolies for X12 now. So --
MR. MAYES: But the process of X12 is different than the process, I think, of these terminologies. AMA does not let anybody come in and -- whoever wants to can go in to X12 and participate fully. There is no -- you know, anybody who wants to can join and participate completely in the development --
MR. ZUBELDIA: -- CPTs, development of the CPTs is copyrighted by the AMA and you can't participate in it.
DR. COHN: And there are a number of terminologies that we are going to be dealing with that have various levels of that. I am actually, once again, only observing that. You know, one has to look at -- I mean, there are --
MR. MAYES: We haven't addressed -- these issues of pricing and exclusive -- monopoly never come in the context we are talking about, monopolies have not come up in the discussions of whether you used NCPDP or X12 or whatever. Primarily, it is because of the way those standards organizations -- one of the reasons the law, I think, actually specified an ANSI-accredited organization is because the ANSI process is seen as a voluntary, open consensus process, in which there isn't an opportunity for an individual organization to somehow gain a financially controlling position on this.
DR. COHN: Okay. And under the legislation, code sets do not have the same requirements, which is probably why the issue comes up.
MR. BLAIR: Could I jump in on this one. I think I am next. I think I am next in line here.
I think the intent of this -- obviously, it touches on sensitive issues. Could I indicate what I think the intent is of this and then if it is off -- if it is not meeting this intent or if the intent is wrong, then that is what I think we need to fix. Okay?
The government is already subsidizing terminologies and the ones that are not subsidized are being -- in some cases, they have to provide funding and so they charge fees. Those may be onerous and some of those -- ones that are not subsidized are adopted by the government, so there is no other choice. Other ones are not adopted. But in either event, you have got a problem here that vendors testified to us time and time again -- I am going back to the vendor testimonies -- that they are afraid that they are going to be burdened with fees if we go forward and we either continue to adopt or mandate certain ones if they are not free.
Well, this is intended to build on the previous one to say, well, how do we rectify that problem and the point on this is that the first we need to do is make sure that the criteria for any adoption in the future is based on characteristics and attributes that we agreed to, so that they promote interoperability.
And then the second thing that we wind up doing is that if the government does provide subsidies -- that is an open door, okay? They can continue to provide subsidies. If they do then they should adhere to those characteristics, in other words, that they meet those characteristics for interoperability and, No. 2, Margaret had up there was that they be accountable. Okay?
So, that at least was my understanding of the problem that this is trying to correct.
DR. COHN: Can I make a comment, Jeff, on this?
MR. BLAIR: Sure.
DR. COHN: Actually, it turns out my memories of the framework actually talks about one of the characteristics as being reasonably priced. I don't know if that meets the needs of the terminology -- actually of the standards developers or vendors, but I think that, once again, most people who supported the framework document felt that reasonable pricing was a desirable characteristic.
MR. BLAIR: I think Clem was also --
DR. COHN: I am sorry. Clem. So, that may address some of that. That is still not free. I guess we need to figure out whether we are -- about free or reasonable price.
MR. BLAIR: Clem, you had a comment? Clem?
DR. MC DONALD: Yes.
MR. BLAIR: At one point you wanted to make a comment here?
DR. MC DONALD: I don't know. I would like to support that we have something in this bullet that -- and there are two different threads. One of them is that the government would likely in some manner subsidize the standards so that it wouldn't inhibit the use of it at some really high fee structure.
On the other side is that whoever got either the subsidy or the monopoly -- and, Bob, I don't mean to say we are trying to make a monopoly. It is just de facto by declaring it the one to the one true, you are going to have that problem. So, having that problem, we have to constrain the bad parts you were talking about like that, than just rip everybody off. There are two ways to do that. One of them is you set price controls and the other one is to scare them about we are going to replace you with someone else to do it. That is Mike's plan.
MR. ZUBELDIA: I think there is a precedent for the government paying for these terminologies in the administrative transactions. Before the adoption of the 4010 standards, Washington Publishing was the company that was publishing the standards, providing the resources to develop the implementation guides and publishing the implementation guides for a profit.
The work was being contributed by the X12 numbers and the developers, but Washington Publishing had costs evolving in creating the development tools and distribution of the standards and was making some profit in the distribution. HCFA came in or the Department came in and said, Washington Publishing, let's negotiate what it would cost to distribute this for free and the Department will pay for that distribution, but we will let Washington Publishing to provide additional means of distribution to create additional sources of revenue if the market wants to pay for something.
The development has continued with the support from Washington Publishing, where people can download from the Web those implementation guides for free, but if you want a computer version copy, like a CD or a paper copy, then you have to pay for it.
This has been a negotiated price between the Department and Washington Publishing, which could be a model for this same --
MR. MAYES: The only difference, Kepa, is that we negotiated a three year contract with Washington Publishing Company with the explicit possibility of opening it up to competition at the end of that period, if I am not mistaken, Mike. Isn't that the final terms?
So, we didn't negotiate with a monopoly. We simply said we will pay you to publish this stuff, but you don't actually own it because the copyright is not maintained by Washington Publishing Company. So, there is a slight difference.
I guess it is just -- you know, it is just odd that this seems to be such a central discussion and I agree with Clem, it is because it is reality in terminologies and, yet, we have effectively potentially created a monopoly in terms of the broader standards, but why has it not been a discussion point there.
I would posit that it is not a discussion point there because structurally the organizations that we chose -- and that is, I think, why it was in the law the way it was, it doesn't lend itself to that -- it is not
-- you know, X12 is not a -- it is an organization, but it is an organization basically of volunteers. It is like a not-for-profit type of thing.
So, there is nobody who is lining their pockets or making big Swiss bank accounts. And I am not accusing the developers of terminologies necessarily of doing that, but the problem with terminology development is that historically a lot of it has been within the purview of very specific organizations that have, you know, members and, yet, they are somewhat restricted. You would have to be in the profession or something like that.
MR. BLAIR: Simon and then myself.
DR. COHN: Yes. I am not sure I want to beat this one into the ground, except to observe that perhaps terminologies are a little different than the X12 standards. In the same way that you negotiated that with the Washington Publishing Company for X12, you also implemented terminologies that were not necessarily all free.
So, I mean, once again, it just speaks to the fact that the terminologies are different. I think many of us have experienced that terminologies cost a lot to develop and build and maintain and either get paid for out of tax money or elsewhere.
Now, having said all that, I still go back to I think there are probably multiple different ways of, I guess, dealing with this one, one of which probably is government monopolies. There is probably also a regulatory approach that may provide some assistance in all of this stuff. And we probably need to look at all methodologies to make sure that the public interests are managed, handled.
Maybe we can begin to cut this one off because there are some other areas down here that I want to make comments on.
MR. BLAIR: Well, my comment is that we had a lot of good discussion on this point. I did, you know -- I did not hear anybody say that these basic points, as far as they go -- people wanted to say, well, we should go further and we can go further when we do the first draft, but do I hear that as far as this one goes, the recommendations are appropriate?
Okay. I don't hear any objection.
DR. FITZMAURICE: Well, I think they are too specific in some ways, when I think they ought to be more general to give latitude for making a judgment at the time and you evaluate the situation. The government should be aware of the issues, know that they may be called upon to make a judgment about the clinical exigence or the monopoly possibilities and should act in the public good in this manner.
Whereas, without the recommendation, they may not be aware of the need to act in the public good.
DR. MC DONALD: I wonder if we can get Mike and Margaret to maybe try another cut at the recommendations.
MS. AMATAYARUL: Will do.
DR. MC DONALD: But I think we do have agreement that we like this direction. Right?
MR. BLAIR: General agreement with the direction. Just some wordsmithing.
DR. MC DONALD: I think it is more than wordsmithing. You are saying here the government should subsidize developers if they only meet these criteria. But that is too directive, I think.
MR. BLAIR: So, we should say "can"?
DR. MC DONALD: "Might."
MR. BLAIR: "Might."
DR. MC DONALD: Or would be encouraged to develop or there would be support for developers, you know, in some circumstances. We have to keep the fear of God in the developers and I think both Bob and Mike bring up good points about how one does it.
MR. BLAIR: Simon.
DR. COHN: I actually -- well, let me make a comment about D and then Bill -- I was going to comment because we keep going on A, B and C forever and we need to wait to see the next version of it before we reengage.
I was actually just going to comment that D, which has to do with the UMLS, the observation is is that there actually -- the legal relationship is clarified and everybody understands it. Most people don't pay any attention to it. Or at least that is the issue, I think, as opposed to an issue about clarifying the relationship.
I mean, it is very well worked out. My understanding is that it is written pretty reasonably and Margaret, you might want to get a copy of that from Betsy Humphries to see if after you received it, whether that is still an issue.
MR. BLAIR: Any other comments on this one?
DR. YASNOFF: This is Bill Yasnoff.
I think there is one thing here that is implicit that maybe we should state explicitly to help people who are reading the report and that is developing and maintaining these terminologies, especially with all these lovely characteristics is quite expensive. That is why this is a problem.
I think it is so obvious to all of us that it is not stated here. So, I think we need to say that.
MR. BLAIR: Okay. Any other additions or comments or modifications?
DR. MC DONALD: I would like -- this is -- no one is going to want to do this probably, but I think it would be good to at least assert that the government would encourage developers to make the codes free and the additional value sold.
MR. BLAIR: Clem, you have got to have it both ways. If you want things to be free, then you have to say the government must subsidize.
DR. MC DONALD: No, I don't. But, no, you don't. There are examples. There are a number of examples where codes are given away and they sell the added value.
MR. BLAIR: You know, Bill Yasnoff just made the point that if you are going to have a robust large terminology, there is cost involved and --
DR. MC DONALD: I disagree. I mean, the example is the device codes. The codes are free and you pay for the knowledge base and the --
MR. BLAIR: Clem, you were not able to produce LOINC(?) at no charge. You needed to have government subsidy.
DR. MC DONALD: I did. Not free. It cost something but no charge.
MR. BLAIR: It is no charge, but you needed to cover costs in the -- you needed government subsidies to do that.
DR. MC DONALD: Yes, but I just -- it still is a nice ideal.
MR. BLAIR: But, Clem, can we put that as an option and then just --
DR. MC DONALD: I just wanted to set it on the table. Forget it.
MR. BLAIR: Well, let's put it -- well, let's put that down as another option because I think there is a qualitative difference between producing LOINC and producing SNOMED. It is just not the same thing and I think -- I agree with you it is a good option and it would be nice if we could do it.
DR. MC DONALD: I don't want to remake -- MEDCIN(?) was a database that is -- 25 bucks a hospital or something and they are obviously just skimming that away and they are going to sell other stuff around it. The outfit that does the device codes, they give away the codes, but the sell the database of knowledge.
MR. BLAIR: Which is the tools that you need to be able to use it.
DR. MC DONALD: Well, the additional value, you need to use it, but others can use the codes. So, there are some examples of that being workable and clearly the Internet, which cost a lot of money, are free.
I mean, there is software involved there. It is not codes. It is software.
DR. YASNOFF: But people sell the software.
DR. MC DONALD: There is always a reference implementation.
DR. YASNOFF: There is a specification that is free.
DR. MC DONALD: No, the software is free. You cannot make an Internet product without making the software.
MR. BLAIR: The reality is that whether you are funding it out of one bucket or another bucket, you still somehow need to fund the development and you are just indicating that there are different models, but there is still funding involved.
DR. YASNOFF: Clem, this idea is now on the draft that is on our screen here.
DR. MC DONALD: Okay. That is all I could ask ever. It is not the key issue for sure.
MS. AMATAYARUL: No. 14, many testifiers indicated that health care processes are highly complex and dynamic, making them difficult to standardize. PMRI is often highly variable, voluminous and needs to be represented in multiple levels of granularity to accommodate multiple purposes.
The recommendation is the government should provide incentives, such as sponsoring workshops or conferences for the development of multiple levels of models, including a meta-data concept model, information model, terminology model and user interface model, which are needed to represent the complexity and multiple uses of PMRI. And we also reference 4A.
DR. COHN: I actually personally thought this was redundant with 4 and I actually thought we should just drop the whole area.
MS. AMATAYARUL: Can we take it out?
DR. COHN: That was my recommendation.
MR. BLAIR: Any objections?
DR. FITZMAURICE: Was No. 4 as specific as this one? Or did we just put them together because of the same concept?
MR. BLAIR: Same concept.
MR. ZUBELDIA: I would take some of the wording of the issue and include that wording in 4, as part of the issue.
MS. FYFFE: I agree with that.
DR. FITZMAURICE: I am sorry?
MR. ZUBELDIA: Take some of the wording on the left hand side of the page and include some of that wording.
DR. FITZMAURICE: Like workshops or conference or the government should promote the development of these things and then say how the government should do it.
DR. COHN: Well, I guess I saw this -- I mean, how is this different than the recommendations in 4 that we were at least at one point asking somebody to do? Am I confused here? Is this something really different?
DR. FITZMAURICE: I don't know if it is different, but I am just trying to get agreement on should the government promote things or should the government promote conferences.
DR. MC DONALD: Well, conferences are designed either to create things or to teach people about things. Which side are you thinking this is supposed to do?
DR. FITZMAURICE: It doesn't say in the wording of it.
DR. MC DONALD: I mean, I almost say, you know, we said on the left side that we have got a real tough problem and on the right side what one would maybe say is one would fund the research and demonstration projects to learn something more about solving these problems. I mean, that is what the usual model is. When you have got a real tough problem, the government says we will do some research in it or we will do tests, we will do something.
DR. FITZMAURICE: Does it say somewhere else in here that we are going to -- the government should fund research? I don't remember.
MR. BLAIR: I think there is another item that says "research."
Margaret?
MS. AMATAYARUL: Yes, there is.
MR. BLAIR: Clem, it has got -- Margaret has it in there in another item a little further down.
DR. MC DONALD: On the other side then, maybe we should be more specific what we are thinking, the conference or workshops. Are we going to teach people about these kind of tools or are we going to try to get a collective together, which will invent them?
MS. AMATAYARUL: Can I ask a question? I am confused. I thought we just said we were going to delete this because it was the same as 4, but we would use some of the verbiage in the issue statement to beef up No. 4's issue statement.
DR. MC DONALD: I like that, well, except I am not sure I like 4, but I like deleting this one.
MS. AMATAYARUL: So, we shouldn't be concerned about developing a recommendation if we are going to delete it.
DR. YASNOFF: May I suggest that when we get to the section that says research, that we can put in the issue of conferences as well at that point?
DR. MC DONALD: Yes.
DR. YASNOFF: So, we could move on then. Delete this one and move on.
MS. AMATAYARUL: Margaret, I think --
MS. AMATAYARUL: I am coming. Just one second. Thanks.
DR. FITZMAURICE: So, the resolution was to merge this with 4? The issue and the recommendation is going to be we are going to bring up this recommendation when we get to the recommendation on research. So, we are not going to forget it.
MS. AMATAYARUL: 15. Most medical terminology developers are promoting the notion that there is no single solution to medical terminology. Users respect the diversity of needs and do not want the richness of medical language to be lost, but need a solution that at least provides an interlocking set of terminologies.
The recommendations are government should adopt core leading medical terminologies for use in government-related projects by the National Cancer Institute, Centers for Disease Control and Prevention, GCPR Project, et cetera, and report to the private sector how they work; thereby influencing acceptance of medical terminology standards.
Also, the government should fund analysis or testing of tools and processes for convergence of medical terminologies and also see also 12A, which is the first one in this set regarding the guiding principles for characteristics and attributes.
DR. MC DONALD: I like it.
DR. FITZMAURICE: I am not sure whether to recommendation that AHRQ be included because we need to have specific terminologies that map from systems to quality measures to the medical knowledge and a linking of us with the National Library of Medicine.
MS. AMATAYARUL: Do you have a new title, Mike?
DR. FITZMAURICE: Yes. Agency for Health Care Research and Quality.
MS. AMATAYARUL: Health Care Research and Quality?
DR. FITZMAURICE: Yes. AHRQ, which is "ARC."
DR. MC DONALD: Is that your new name?
DR. FITZMAURICE: Yes, that is our new name.
DR. MC DONALD: Damn, I didn't know that.
DR. FITZMAURICE: The President just signed it yesterday.
MR. BLAIR: Agency for Health Care Quality -- Agency for Health Care Research Quality.
DR. FITZMAURICE: The name is "ARC" and since John Eisenberg is our director, he is now John of ARC.
At least I got a small laugh from Clem. It is better than the grimaces I got around the table.
MS. AMATAYARUL: AHCRQ?
DR. FITZMAURICE: AHRQ.
PARTICIPANT: Better use that one as often as you can very soon because it is going to get old right away.
DR. COHN: Margaret, the only thing I would add to this because I think otherwise it is fine -- and this is a question that maybe we will bring up and talk about in January, is the question of whether we want to get anymore specific in relationship to these core leading medical terminologies. I don't want to discuss that right now, I don't think, but I just don't want to forget that as an issue about whether we want to press this one.
MS. GREENBERG: Just for clarification, throughout this section, you have been talking about terminologies for patient medical record information. Correct? Sometimes people include classifications in their concept of terminologies, though I think there is acceptance -- growing acceptance that there is this continuum and the classifications are not the same as terminologies. Is that what we all agree on?
DR. COHN: Actually I am using this in the concept of -- as we described the framework, which is the continuum. I don't know what Jeff is --
MR. BLAIR: Again, I am not sure. Say that, again. I didn't quite -- I thought I understood and then I lost it.
MS. GREENBERG: Such as these criteria, going back to No. 12, those are characteristics for terminologies for patient medical record information. They aren't necessarily all characteristics of classifications.
MR. BLAIR: Oh, you are right.
MS. GREENBERG: And, in fact, I think -- but I just wanted to make sure that we were all -- sometimes people in talking blur between the distinctions between terminologies and classifications, but here I assume that we are talking about terminologies throughout. When you got over here to the government should adopt four leading medical terminologies, are you talking about for uses beyond patient medical record information?
MR. BLAIR: Could I address that? I think the testimony that we heard was that we needed clinically specific terminologies at the point of care to capture information for the purposes of patient care and that -- and I think that is in there. There is a reference in there in the global principles on this. And that that information would then be a base of information from which information would be derived for research, for reimbursement purposes and for other purposes.
So, there is a relationship there. That was originally from Jim Simino. I think he wound up saying that as one of the principles and characteristics and attributes and then it was reiterated, I think by Keith Campbell and then by a few of the vendors.
MS. AMATAYARUL: I think if we look at No. 20 and No. 23, No. 24, some of those may address how the classifications -- Marjorie, what I think you are talking about in relation to medical terminologies. You might want to hold that thought and let's finish this section and see if --
MS. GREENBERG: But, see, now here is where you go down to 23 and say many testifiers indicated that the most widely used terminologies -- and there is a problem. ICD and CPT. ICD is not a terminology. It is a classification.
MS. AMATAYARUL: We treated all of these things under an umbrella of medical terminology and then identified issues and recommendations to treat some of them differently.
MS. GREENBERG: I mean, are you suggesting that ICD should go to context-free identifiers? That would be quite a change for --
DR. COHN: Well, I guess it is a question of whether it wants to be used for patient medical record information.
MS. GREENBERG: Huh?
DR. COHN: Did ICD want to be considered as a terminology for patient medical record information uses?
MS. GREENBERG: No.
DR. COHN: Well, in that case, you don't have to.
PARTICIPANT: That is a coding system.
MS. GREENBERG: Okay. But it is not clear where you are talking -- and it is sort of going back to where you said you wanted -- you were speaking about health care information and we made that back to patient medical record information. But here when you get to 23, you are referring to ICD as a terminology and then I wasn't quite sure what you had in mind under 15A.
MR. BLAIR: Margaret is correct. When we were doing this, the umbrella phrase that we used was medical terminologies and then within that we were more sharply focused on the terminologies or patient medical record information, which is a subset of medical terminologies in general. But I think what you are saying is that we really should not include -- are you saying that we should not include ICD under the banner of medical terminologies because it is a classification system?
MS. GREENBERG: Basically, yes. It is not viewed as a terminology -- I mean, it may be viewed by some as a terminology, but that really isn't what it is. It is a classification system.
MS. AMATAYARUL: We will fix that.
MS. GREENBERG: But, again, what -- a little clarification about what you have in mind here -- well, I see you are using the word because like in 24, you say mapping back to terminologies required for statistical and reimbursement purposes. I think what you mean there is probably classifications.
MR. BLAIR: Good. Good catch.
DR. COHN: Well, except that some things you map back to terminologies.
[Multiple discussions.]
MS. GREENBERG: Terminologies and classifications. You might want to say both.
But what types of projects are you thinking here, like NCI. They use ICD-O. I am not quite sure what -- are you talking specifically about patient -- if any of these agencies are developing standards or patient medical record information or are you talking about broader activities by these organizations?
MS. AMATAYARUL: I don't think we had specific projects in mind. I think the testifiers basically had identified these agencies as if they have projects that would use patient medical record information that they use core-leading terminologies when they do those projects. I didn't get the impression that they had specific projects in mind.
MS. GREENBERG: The GCPR is a clear one because that is a patient medical record project. I just think that needs -- you know, that is a pretty broad statement and it needs a little more vetting or understanding what is in mind here because they have a lot of different kinds of -- I mean, these organizations have a lot of different data collections. Some use terminologies in the PMRI sense. Some use other things.
DR. YASNOFF: Marjorie, would you be happier if it said projects involving PMRI information, like we did before?
MS. GREENBERG: That is more what --
DR. YASNOFF: I think that is what it means.
MS. GREENBERG: -- is appropriate.
DR. YASNOFF: Yes. I think that is what it means.
DR. FITZMAURICE: That is a good fix.
DR. YASNOFF: Because that certainly is our intent at CDC is when we are dealing with PMRI information, we are not going to make up our own standards. But if we are dealing with some other information, who knows what we might do? We might actually set our own standards.
MR. BLAIR: Margaret, I think we are --
MS. AMATAYARUL: 16. Several testifiers identified both gaps and overlaps in the existing set of medical terminologies. The gaps include terminology for complementary medicine, environmental stressors, preventive care, information relating to the human genome and potentially other areas. And we referenced 4A, which relates to the role of the ANSI HISB, coordinating and using a reference information model to identify gaps and overlap.
DR. YASNOFF: Can we also reference -- while we have been talking, I looked ahead and it is 20B, which is the research recommendation, which says the following: The government should fund research to study the impact on quality of care of health care information systems and clinically specifically medical terminologies to achieve comparability of data. Can we reference that one here at 16, again, related to Clem's point that we have gaps and overlaps and one of the things we should do is we should fund research to deal with those.
DR. MC DONALD: Just two suggestions.
MR. BLAIR: Can we recognize Clem or are you still talking there?
DR. MC DONALD: I am happy to wait. I just can't see who is lined up.
MR. BLAIR: Right. Clem, I think you are next.
DR. MC DONALD: Now?
MR. BLAIR: Yes.
DR. MC DONALD: Two thoughts. One is that when you put in specific gaps, you may be begging for complaints. So that I don't know if I would -- who is not listed? Who should be listed? You end up with a lot of comments you wouldn't otherwise have to get.
Further, I think there is a tremendous stuff -- there is a vocabulary that is pretty rich for the human genome. So, this is a question about whether you really want to be specific.
The second part is why don't we have a specific item that will be some kind of a -- Margaret, you described looking at the data model to decide where the gaps are. I don't think you can do it that way. I think you have to have some organization or structure where people can say that we are missing vocabulary and we need it.
MS. AMATAYARUL: That was a recommendation 4A, identified ANSI HISB or another organization to do that.
DR. MC DONALD: But in your discussion, your verbal discussion, you just said that they would examine the data model to decide the gaps.
MS. AMATAYARUL: This organization would?
DR. MC DONALD: No. That is how the gaps would be found in vocabulary. I don't think that is how it can be found. I think it is sort of an empirical thing. People find out they don't have the vocabulary they need and they just need someplace to go to ask for it.
Maybe, I think, what you probably should do is -- well, this is -- the vocabulary isn't well-represented in HISB. Maybe you really need to talk about having a vocabulary group, maybe hosted by the NLM, that would help deal with this.
DR. COHN: Actually, Clem, can I chime in here. Actually, I have another thought on this one, which is it seems like this actually may be a role for the NCVHS in the sense that every year we are going to be having hearings to look at changes, updates, modifications to the HIPAA standards and that may be -- and, obviously, code sets are part of that. So, I think we will be looking for input from areas where gaps are perceived.
DR. MC DONALD: Are you suggesting that NCVHS should be a vehicle to receive that?
DR. COHN: Well, I think it is likely to be the vehicle to receive that.
DR. MC DONALD: Okay. Then I would put that down then. I like that.
DR. COHN: I think this will be an ongoing process.
MS. AMATAYARUL: Can I ask a question?
I put down NCVHS should be the vehicle for vocabulary coordination or --
DR. MC DONALD: No, no. Identify the gaps and overlaps. I mean, to receive suggestions from the public about gaps and overlaps.
DR. FITZMAURICE: Well, I would also say that HISB could do that as well. CPRI could do that and they might also be well-advised to go to a standard development organization for assistance in getting development of that. It is hard to pin just one place.
DR. MC DONALD: Well, this is the place that is designated by law that worry about standards, NCHS. So, it is not a radical position. Vocabularies are not the same as the message standards developers and I don't think we should lump them.
DR. COHN: And I think, Clem, that actually our role is not only just to receive suggestions and that may be less. It is actually more make recommendations to the Secretary on how to resolve these gaps.
DR. MC DONALD: I think LOM has more experience with vocabulary than just about anybody with the EMLS. Why not have them listed as a potential?
DR. COHN: Good point. I think that is actually an excellent idea.
DR. YASNOFF: Can we get rid of either vehicle, too. So, it sends NCVHS should receive suggestion from the public to -- and identify and make recommendations to the Secretary regarding -- because by getting rid of that, then you accommodate Mike's suggestion about, you know, this isn't the only way it could be done, but this is a way that it can be done. We are recommending.
MS. AMATAYARUL: How do I get NLM in there?
DR. YASNOFF: How about NCVHS in consultation with NLM? How does that sound?
Simon, does that sound good to you?
DR. COHN: Let's try it.
I am sorry Betsy isn't here for her to comment.
MS. AMATAYARUL: NCVHS in consultation with NLM should receive suggestions from the public to identify and make recommendations to the Secretary regarding vocabulary gaps.
DR. YASNOFF: How about getting rid of should receive suggestions from the public and just say should identify and make recommendations to the Secretary regarding vocabulary gaps? I am sure the public will find their way.
MR. BLAIR: I have one other little comment here.
Clem, at the beginning of our session today we all identified any areas where we had membership or where we have received income. While I did that at that time and I identified that I, you know, was on ANSI HISB and was an executive committee member, at this point -- and I really want to go further than that and recuse myself from any discussion from that. I am going to be very specific here.
My employer at the Medical Records Institute happens to be the chair of ANSI HISB. There have been no questions, comments, discussions between the two of us on ANSI HISB, but just to completely avoid any perception whatever on my part, I am just going to completely recuse myself of any further comments with respect to any role of ANSI HISB in these discussions.
17.
MS. AMATAYARUL: 17. Several testifiers indicated that incompatible drug knowledge bases impairs the ability to perform drug utilization review enterprise by drug formulary usage, the ability to control the cost of drug usage, et cetera.
The recommendation is the government should mandate a quality standard that requires drug interaction assessment be done at the point of care, which would drive the convergence of drug knowledge bases. We also referred to 12A, which is the criteria.
DR. COHN: Bill Yasnoff and then I want to comment.
DR. YASNOFF: There is a confusion here between drug knowledge bases and drug terminology databases. Okay? There are already competing drug knowledge bases and I am not sure that isn't a good thing to have those competing -- in particular, with respect to this recommendation, there are several competitive drug interaction databases, any of which could be used for this application.
So, I certainly would agree that the government should mandate a quality standard that requires drug interaction assessment be done at the point of care. But I don't think that has anything to do with this group. This is related to the -- I mean, we are kind of -- I guess we were anticipating the IOM report on errors with this one. I do not think that this in any way would drive the convergence of drug knowledge bases or terminologies at all.
DR. MC DONALD: I agree.
DR. YASNOFF: I mean, this is -- there are two things here. Mandating this quality standard requiring drug interaction assessment, which is a good thing, but I don't think relates to what we are doing and driving the convergence to drug knowledge bases, which is not -- I don't think we want to do that because the drug knowledge bases are competitors and that is fine. But what we do want to do, perhaps, is drive the convergence of drug terminology but this isn't going to do it.
DR. COHN: Yes. Bill, maybe I can follow-up on that one because actually I can agree with you . I was thinking about this last night and I think that there is a sort of gap right now as best I can describe it. We have NDC, which is --
DR. YASNOFF: You don't even want to characterize this.
DR. COHN: I don't think I would want to characterize it.
DR. YASNOFF: I think everyone would agree it exists.
DR. MC DONALD: I think we should strike this one. We have lots and lots of suggestions and this one doesn't quite fit.
DR. COHN: Okay, Clem. Can I finish my comment?
DR. MC DONALD: Yes.
DR. COHN: Okay. And then we have knowledge bases. What we really don't have is robust drug terminology, at least as best I can describe it. As I look at what needs to be for drug terminology, it needs to have the NDC. It needs to have a generic name. It needs to have trade names and it needs to have --
DR. MC DONALD: Simon, I can't -- you are the one I can't hear very well.
DR. COHN: Okay. I am sorry. Here we go. For some reason this thing isn't working. I guess I need to have it closer to my mouth. Okay.
What I am saying is is we have knowledge bases. We have a listing, which is the NDC. What we don't have really is a drug terminology currently. Though the knowledge bases actually, I think, implement various source of drug terminologies. What I think that there is probably a need for is a drug terminology that consists of the NDC codes, generic names, trade names and classes and I think that that is part -- this is the part that appears, at least to me, to be missing.
Now, I don't know how we get that.
DR. FITZMAURICE: Simon, might that be a classification, rather than a terminology?
DR. YASNOFF: That would fall in classification.
DR. COHN: Okay.
DR. YASNOFF: But we could say as a recommendation that the government encouraged the development of this and just leave it at that for right now.
DR. COHN: Okay. But I guess -- am I close to what you should be doing?
DR. YASNOFF: Yes.
DR. MC DONALD: This particular area is all we are going to do is catch flak for because the number of companies has boiled down to almost one, maybe there are 2 1/2 now, by purchases and all.
I don't think that this is -- the argument of the antecedent and consequent connect at all as the reason you heard earlier and we are really -- getting really -- it is not the generic area. If you were getting down to the details, I am afraid this one is just going to catch hack flak without any huge value from it. And the report will get less use if we have a thousand recommendations than if we have five.
No, I mean, you want to catch their attention. I don't disagree with what you are saying because I think it would be nice to have that, but there are another 20 things it would be nice to have that we haven't mentioned.
DR. YASNOFF: Well, but before we give that up -- you made a good point, Clem, which I think I tried to make, that the assumption here about the incompatible drug knowledge bases, that is incorrect. We do not have -- we have incompatible drug terminologies. It is not the knowledge bases. Of course, the knowledge bases are incompatible, but that is not the issue. The issue is -- the issue we are really trying to capture and that you are trying to address, Simon, with your recommendation is drug terminology, not drug knowledge bases.
It is perfectly fine to have 57 drug knowledge bases in competition, as far as I can see.
MR. BLAIR: Could I ask for a point of clarification on this and that is that they seem to refer to -- at least my understanding is they refer to their terminologies as drug knowledge bases. Now, I am not aware that they are different than terminologies. If you are, please educate us.
DR. YASNOFF: Let me explain the distinction that at least I am making and it may be wrong or confusing and that is that to me drug terminology is some kind of listing of drug names and characteristics of those drug names. As Simon was pointing out, we need -- a drug knowledge base is someplace I can go to find out some information about that drug. What are the indications for that drug? What are the dosage forms? If I am giving two different drugs, what are the interactions between those two drugs that have been reported and are they major or minor?
That is knowledge about the drugs. I think it is wonderful that there are various competitive -- although as Clem points out, the number of competitors is decreasing. I think that is wonderful and we need to leave that alone, but what I recalled in the testimony was people were saying that the codes for identifying drugs are just not adequate.
Kepa, I hope you are going to really explain this to us.
MR. ZUBELDIA: No. But I am wondering if the subject of knowledge bases in general is outside of the scope of what we are trying to do because terminology should be standard, but the knowledge base is something completely outside of our scope. It is the application of the terminology.
MR. BLAIR: My understanding is this does get down to the core issue that we are struggling with, which is that within clinical settings if they have one vendor, it is unable to communicate clinically specific drug information, medication information from one system to another. So, if there are integrated delivery systems and there are two different hospitals and they have two different vendors, they cannot -- the information is not interoperable for clinical use.
DR. YASNOFF: That is a terminology issue, though, Jeff.
MR. BLAIR: That is a terminology issue, but my understanding is that it is because of the incompatibility in the drug knowledge bases.
DR. YASNOFF: It is because the drug knowledge bases are not indexed with a uniform reference terminology that allows you to take a drug and go into the knowledge bases. But it is a terminology issue not
-- it is like one library uses the Dewey Decimal System and another library uses, you know, some other system .
MR. BLAIR: Right. And in the discussions that I have sat in on on the vocab technical committee at HL7, it appears to me -- at least I have gotten the impression that the NDC codes are, in fact, a classification system and they do not -- at least this was my understanding -- they do not seem to be suggesting that the NDC codes can be enhanced or improved. They would have to be completely rearchitected to become a reference terminology for drugs.
DR. FITZMAURICE: There is another alternative and that is to impose a classification between the terminology and the NDC classification so that you lump like things together where like refers to medical knowledge. Now, you have a different classification that lumps like things together when you are talking about bauxites, for example. It is the classification that needs to link with the medical knowledge.
MR. ZUBELDIA: This is going to become a huge problem on the adjudication of claims with NDC codes because they don't have a terminology. Getting the NDC codes really doesn't tell you much unless you have exact pricing for that one NDC code.
DR. YASNOFF: Because it is used for packaging.
MR. ZUBELDIA: It is packaging, but I think mapping the NDC codes into a terminology is possible. I think if there is a standard terminology, each NDC code should have an indication of what is the actual drug for that NDC code, according to a standard terminology. Then the NDC code then mapped into a terminology could be used to map from one system to another.
So, the trick is to have a terminology.
DR. YASNOFF: But what 17 should say is several testifiers indicated that incompatible drug terminology impairs the ability, blah, blah, blah. Right?
MR. BLAIR: Okay. That would --
DR. YASNOFF: And then the recommendation should be what Simon said.
MR. BLAIR: I think Simon is addressing one part of the problem, but I don't know that that is all of it.
Simon, you wanted to make a comment.
DR. COHN: Well, I guess I would let you tell me what the other part is before I --
MR. BLAIR: Well, my understanding is that you still need a drug reference terminology that complies with the ontological principles, that complies with the characteristics that we listed in Item 1, in order to be interoperable and that that is also needed beyond any improvement.
There still may be improvements to the NDC code, but the NDC code has the purpose -- I don't know if Clem can hear me -- has the purpose of meeting the needs for manufacturers, who are doing packaging, not for clinical use. So, my impression is that we still need a reference terminology for clinical use.
DR. COHN: Yes. I guess I am not sure how what you just said differs from what I was saying. Once again, I am not sure exactly what it -- when you start talking about drug reference terminologies, it depends on I guess what you mean by a drug reference terminology.
I do, however, want to make one comment and then Margaret A. has a comment. This is, I think, a very important issue and I know Clem commented there are lots of other areas, but the reality is that this is one of the big areas where there are still problems and, yes, we can talk about history and physical, but this is an area that -- especially with the patient safety stuff and all of that, the spotlight is shown on this area.
DR. YASNOFF: Simon, would you accept -- to incorporate what Jeff said into what you said? We say government should encourage the development of a drug reference terminology classification that incorporates, et cetera, et cetera.
DR. COHN: Yes, I --
DR. YASNOFF: And then I think that covers -- I think then I hear total agreement.
MR. ZUBELDIA: On that comment that Margaret wrote on the left, it says this is going to become more acute with the use of transaction standards. Let me point out that with the J codes and the HCPCS, we had more of a terminology than what we will have with the NDC codes that are going to replace the J codes. At least the J codes, say, penicillin, didn't specify brand or anything else. It just said penicillin; whereas, now going with the NDC codes, we have a mess because each manufacturer has a different NDC code and it doesn't get us any closer to what we want.
DR. YASNOFF: And maybe this is a good place to say that this is important for patient safety issues. So, we can link this recommendation to those issues.
MR. BLAIR: Very good point.
DR. YASNOFF: So, let's not lose that point.
MR. BLAIR: Margaret, I think we are ready to go on to our next item, 20.
MS. GREENBERG: Were you talking about needing -- what do you mean by terminology/classification there?
MS. AMATAYARUL: I think we need to go back and look at the words "terminology," "classification" and "code set" and with your help make sure that we are using the terms appropriately. I think we just need to go back and do that.
DR. FITZMAURICE: And it would help, too, to have a medical example of how you could go wrong. If you are trying to classify drugs one way and you need to classify them another way because you are looking at adverse results or you are looking at things that can be used to treat a particular disease, you might have several different classifications for clinical use and we need to determine what the problem is that this solution we have specified will fix.
Is that a pricing problem that I don't know what price to put because it could be a large box or a small box or -- I don't know if this is penicillin or not because I don't have a list of all the codes that refer to penicillin.
You won't have a problem finding examples of problems.
MR. BLAIR: The next item.
MS. AMATAYARUL: The next item was 18 and --
MR. BLAIR: We crossed that out.
MS. AMATAYARUL: We crossed that out. We also crossed out 19. But this is Jeff and I that crossed them out, not you folks from before. So, I just left them in there so you could see what I crossed out.
MR. BLAIR: We didn't want to cross out anything and not have you verify that it was appropriate for us to eliminate them.
MS. AMATAYARUL: So, the next one that we have not crossed out is several testifiers observed that there are few health care information systems today that are capable of supporting the practitioner and capturing clinically specific data at the point of care.
Once data are captured for patient care purposes, all information required for other purposes, such as reimbursement, public health, research and other uses of data should be derived therefrom.
The recommendations were: The government should adopt guiding principles for PMRI that recognize the concept of capturing clinically specific information at the point of care in a manner that allows for derivatives of that data to be used for reimbursement, public health, research and other purposes.
A second recommendation is the government should fund research to study the impact on quality of care, of health care information systems and clinically specific medical terminologies to achieve comparability of data.
MS. GREENBERG: I don't understand B there.
DR. MC DONALD: Margaret, I think the intent here is good, but I don't think -- the sentences aren't coming out right.
MS. AMATAYARUL: Help me, Clem.
DR. COHN: Can I make a comment before you even do that? I am actually not sure of the difference between 20 and 24 because really what you are talking about, I think, is mapping, I think. You are talking about having data -- I mean, having terminologies that work and having them map to other things so that they can be used for multiple purposes.
I mean, I think -- and once again, that is the issue, as opposed to the recommendation. They are different.
MR. BLAIR: I think that that is also a valid point, but I thought that the first recommendation -- well, first of all, I think the first recommendation is not already in the guiding principles that Michael had and it would be an addition to those guiding principles.
Could we kind of do these one at a time and make sure we agree on them? Is that okay?
Do we all agree that that first recommendation should be added to the guiding principles?
MS. AMATAYARUL: Can I make a comment?
Simon, you had said you thought this was like 24 and maybe we need to address the issue before we go to the recommendation. Twenty is focused really on user interface. It is point of care systems. It is getting people to record documentation in the medical record that is done in a medical terminology. That is the point really of 20. And then 24 is mapping.
Capturing clinical documentation through the use of medical terminology, the user interface, the use of an information system. That is 20.
Twenty-four is then to say and it follows, once you have captured the data in a medical terminology, in a controlled medical terminology, you would then be able to take that data and map to whatever other uses you had for the data, if you needed to map to ICD, if you needed to map to whatever.
DR. COHN: Oh, okay. Can I just make a comment because that is actually not how I was reading it because I was sort of thinking, well, gee, there are actually lots of systems out there that capture free text, which typically is clinically specific data and data from that is -- you use that data to drive to you for other purposes.
So, you are saying that somehow you really mean clinically specific medical terminologies. Okay. That is a helpful clarification for me.
MR. BLAIR: When the testifiers used the words "user" --
MS. GREENBERG: -- using free text or there should be some interface between --
DR. COHN: They are talking about some sort of medical terminology issue, I think.
MS. AMATAYARUL: Either structured or whatever.
MR. BLAIR: However it is captured. See, the thing that was maybe misleading is the testifiers used the word "user interface." I tend to think of capturing information at the point of care. So, maybe that word "user interface" may have --
DR. COHN: Well, I guess in that case, it is very similar to 30, which is -- No. 30, it says data are often imbedded in text strings, not as discrete data elements making extraction functions impaired.
MR. BLAIR: They are related, but, again, we tried -- and in some cases, we have lumped too many things together and in others, you know, we tried to split them apart so they could be looked at without confusion.
MS. AMATAYARUL: Simon, 30 is also under the category of data quality was the reason.
DR. COHN: Okay. Well, let me then just make a comment and then I will stop on this one.
I am actually concerned about the open-endedness of this particular recommendation. I think early on when we were talking -- and, once again, this was probably a year ago in our hearings -- we identified that there are probably some important data fields and some information that was very important to focus on getting clinically specific structured text, which is really what you are talking about here.
In other areas, where there probably was very little evidence that it mattered -- and I, for example, would indicate the problem list, reasons for visits, indications for orders, diagnosis, procedures, treatments, are areas where I think this applies to, but I would wonder if we would -- but, to me, those are the important areas and I would wonder really if we want to apply the same question and issue to history and physical.
MS. AMATAYARUL: So, your recommendation, Simon, might be a more focused research study on certain data sets -- not data sets in the sense of minimum data sets --
DR. COHN: Fields.
MS. AMATAYARUL: Data fields.
DR. COHN: Data elements or whatever. It is just another way of looking at this, which makes it a little more focused.
MR. BLAIR: Could I go back to our -- I am trying to keep us focused on a point at a time. That very first recommendation that Margaret read to us on this one, is there agreement on that piece? Because I have not heard any disagreement.
DR. FITZMAURICE: Let me voice some disagreement on it. The issue is two things. One, how do you capture clinically specific data and the second one is a workable process.
It would seem to be efficient to capture it once and to use it many times. It would seem to be. I am not sure that that has been proven or demonstrated in actual fact. We don't see an awful lot of places doing it.
So, I would think that was -- that is probably a research or a demonstration issue, not an issue that the government should come out full force on.
DR. MC DONALD: I agree. B is the one that is more appropriate.
MR. ZUBELDIA: And I have a concern with that in that the way it reads, it seems like it may be later on that the responsibility for capturing the data for other uses would fall onto the person capturing the data at the point of care.
MR. BLAIR: Now, if we abandon that recommendation, there are some implications that could be very costly because what it is saying is that if you don't try to capture information for clinical purposes and then use derivatives of that for other purposes, you are going to say that it is okay to impose on the clinician. I want you to do separate documentation for reimbursement. I want you to do separate documentation for research. I want you to do -- this was an intention to say maybe we could become more efficient if we could move information systems where when you capture information for patient care, you capture it completely enough and clinically specifically enough that those other things can be derivatives of that.
Now, maybe we won't be able to a hundred percent meet that goal, but I think it is a very important concept that if we could work towards that goal, we reduce costs and we reduce the burden on the clinician.
DR. FITZMAURICE: I believe in the concept I just can't support it with empirical evidence at this point.
MR. BLAIR: No, I agree with you. There is a lack -- we haven't achieved that, but if you do say -- the first piece that you said you would agree on that as a goal.
DR. FITZMAURICE: It should be tested.
MR. BLAIR: Clem, you were going to say?
DR. MC DONALD: Well, no. I mean, I am kind of in between. There are two parts -- the sentence actually -- as it is stated, the first sentence doesn't say really what we want it to say. We can recognize the concept and so what? I recognize that this concept exists. What is that really saying? I think that is not what you really want, is it?
Should adopt a guidance that would recognize the capture of -- I think we have got our -- the words are wrong, but the challenge here is what you are really -- what you said, Jeff, is, yes, if they are going to do stuff, capture data, you don't want to do it on paper form and on a clinical form, because people are now dictating and you are converting them to an on-line choice maker, you have got to -- we have a real question of whether that is more efficient. And you might have a revolt, too.
The competition for physicians is dictation versus trying to do a multiple choice stream.
MR. BLAIR: I don't care how -- Clem, this is not saying that you use structured data entry or that you use voice recognition. It is not saying that. What it is trying to do is avoid a situation where secondary users of clinical information are demanding and imposing a completely separate process to get that information.
DR. MC DONALD: Well, maybe what we should say is that directly, is that the guiding principle is that secondary users should depend upon the primary clinical data capture, issue it that way.
DR. COHN: I am not sure based on the discussion, it should even be in this section.
DR. YASNOFF: The second point, B, which is -- I read as the government should fund research -- fund both of these and say since it is an important goal that clinical information be captured once for both primary and all secondary uses, the government should fund research into methodologies that allow you to do this. But that is not what this B says at all.
DR. COHN: Here, here.
DR. FITZMAURICE: I like what you said, Bill.
MR. BLAIR: I do, too.
MS. GREENBERG: Yes. Sounded good.
MR. BLAIR: Margaret, can you capture that?
DR. YASNOFF: But I want to still talk about what it says in B now because although I don't think that relates to the point in 20, I think that the government should fund research and medical terminologies and we need to put that maybe somewhere else and reword that.
MR. BLAIR: Could you give Margaret a chance to capture your phrase?
PARTICIPANT: She did.
MR. BLAIR: So fast?
DR. YASNOFF: You mean, I have to say that again.
MR. BLAIR: You already got it?
Now, is it just that it should fund research or it should -- because I think it is more than just funding research. It is also trying to promote the goal.
MS. AMATAYARUL: Could I just make sure I have this?
MR. BLAIR: Okay.
MS. AMATAYARUL: Since it is an important goal to capture data once for primary and secondary uses, the government should support research/demonstration projects to evaluate the efficiency of capturing clinically specific information at the point of care in a manner that allows for derivatives of that data to be used for reimbursement of public health research and other purposes. That is one recommendation.
Then a second recommendation is secondary uses should depend on the primary data capture.
DR. COHN: That is repetitive.
MS. AMATAYARUL: That is what I thought.
And then a second one is the government should fund research to study the impact on quality of health care information systems you want deleted?
DR. YASNOFF: Well, maybe that belongs in the quality section or something, but this is kind of -- talks about quality and terminologies. But the quality is -- what I think you are getting at is the government should fund research to see what the impact of the use of terminologies is on quality of care. Is that what -- okay. That is one issue.
Then the issue of the government should fund research in how to better develop, organize, publish, disseminate, promulgate, promote medical terminologies. That is a separate issue. Neither of those issues has anything to do with this point. But they are good recommendations but they just don't -- I don't see that they relate to this point 20 on the left.
DR. FITZMAURICE: We might want to add to the end of yours common medical terminologies or mappable terminologies, so that we don't have a lot of them. We don't want one of them, except it creates a monopolist.
MS. AMATAYARUL: Can I have you take a look at this and help me out with the other part? It should be developed? Is that what you were --
DR. YASNOFF: How the use of common mappable terminologies can improve the quality of health care. That is one.
MS. AMATAYARUL: That is up above.
DR. YASNOFF: I already said that?
MS. AMATAYARUL: Yes. I have got that.
DR. YASNOFF: No, the A -- what you have listed as A has to do with funding research on the capture of data in a way that allows for derivatives to be used.
There is a second area of research, which is how the use of terminology can improve the quality of care. That is --
DR. COHN: That is C. Isn't that C?
PARTICIPANT: She added it to A.
DR. YASNOFF: She added it to A. Okay. I am sorry. No -- yes. C is the existing B, which is kind of a mish-mash of quality of care and medical terminologies and I am trying to separate that into two parts. One is research into how the use of medical terminologies affects the quality of care and the second part is research into how to better develop more medical terminologies period. More effective. We don't want more medical terminologies. More standards is not what we need.
MR. BLAIR: Question or are you in the middle of --
DR. YASNOFF: -- research on how the use of common mappable terminologies affects the quality -- yes. Now, these are not -- we have captured these but they don't belong here.
MR. BLAIR: Before you start to move them, you have limited this just to research. I would think that the government's role in pursuing this is a little broader than just research because there is terminology developers and vendors that are making progress towards this on their own.
I would want to make sure that it is that the government would promote these things, including research. Research is a subset of --
DR. YASNOFF: Right. I agree. All I was trying to do was take 20B and kind of -- it was confusing to me -- and try to split it out into two ideas. I am not trying to in any way limit anything. I am just trying to make sure that the thoughts that I think are meant to be expressed in 20B are expressed more clearly and then once they are expressed more clearly, let's put them someplace more appropriate.
MS. AMATAYARUL: Do you have a suggestion for where we should move these to?
DR. YASNOFF: Well, 20 -- when I -- in 16, 16 is the one where we say gaps and overlaps in existing sets of medical terminology -- I know Clem doesn't like the gaps business, but there are needs for additional work in medical terminologies. That is where I thought, you know, the government should fund research in medical terminologies. Those things seem related to me. There are gaps or there are needs or the medical terminologies we have are not ideal.
So, that is where research should go. And then the quality one should go somewhere in the quality section. I don't know where. I am not that far ahead of where we are.
MR. BLAIR: I have had a suggestion here. It is a little after 5:00. Michael and Susan Bebee also made the same suggestion and I think some others felt this way -- is we don't want to lose -- like Clem is available right now and the thought was for us to continue working past 5:30 because they felt that there were a lot of important issues and we didn't want to truncate the discussions, but I didn't know how the work group felt about, you know, can we continue working past 5:30?
DR. COHN: Let's rediscuss it at 5:30. I am fine with it.
[Multiple discussions.]
DR. MC DONALD: I may have to break and get a Coke.
MR. BLAIR: Let's not lose our time here. Move on.
DR. YASNOFF: So, what we are going to do is when we -- why don't we for sake of time just leave these things here and then when we get to other areas, we can move them if we think of it.
PARTICIPANT: The next one is 23.
DR. COHN: Yes. And actually E you can forget because it doesn't seem like it is applicable any longer in there.
MS. AMATAYARUL: Twenty-three is many testifiers indicated that the most widely used terminologies, ICD and CPT have addressed the expression of medical language for statistical classification and reimbursement purposes, but they have not adequately addressed the need for the kind of data necessary to support evidence-based medicine.
Recommendation A is the government should adopt standards for quality of care that will require comparable data and, thereby, drive adoption of medical terminology standards. See also 12A, which is the criteria.
The government should establish minimum data sets and requirements to report on compliance with quality of care standards. The government should adopt a standard data dictionary for reporting of existing public health functions.
DR. COHN: In what time frame?
MS. GREENBERG: These don't seem to go together either.
MR. BLAIR: Again, I think that it will be helpful for us -- could we deal with them one at a time and see where we agree and disagree?
MS. GREENBERG: How about the left column here. I had raised some issues before about referring to ICD and CPT as terminologies, certainly ICD.
DR. COHN: Well, one of them is a terminology. We know that since there is a "T" there.
Let me just short circuit this one because I found myself crossing this out only because --
MR. BLAIR: Crossing all four recommendations?
DR. COHN: -- thing out only because I thought -- and I guess this would be a question. I mean, it seems like more of a research agenda than anything else at this point or more proof of concept.
DR. FITZMAURICE: I see nothing wrong with the research agenda. I would like to change B when we get down to it.
MR. BLAIR: Again, we are sort of jumping around here. Could we just see -- do we agree with A or not? Is that in or out?
MS. GREENBERG: You rejected my --
MR. BLAIR: No, we didn't -- I think that Margaret should clarify the terminology and classification in that?
MS. GREENBERG: Okay. That is part of the overall clarification.
DR. FITZMAURICE: Right. We agreed to that. And that is in there.
MR. BLAIR: I am sorry. I just assumed that she was correcting it.
PARTICIPANT: She did.
MS. AMATAYARUL: I did but I didn't correct "forward."
Simon, the first recommendation relates to the fact that a lot of testifiers suggested that if standards for quality of care, like Joint Commission, Orex(?) and HEADUS(?), but even more specific performance measures were adopted that required use of a medical terminology, that that would promote the adoption of medical terminology.
DR. FITZMAURICE: I would word that one differently a little bit. I wouldn't have the government adopting standards for quality of care. This is what you must have, what you must achieve it. I seem to remember something about practice guidelines and a former agency
-- we were associated with, but I see nothing wrong with looking at consensus quality of care performance measures and investigating what comparable data are needed to obtain those measures. I would have the government work with the private sector, in collaboration with the private sector to establish or develop minimum data sets and reporting requirements.
MR. BLAIR: My understanding was that they were saying the government makes -- there are very strong incentives in place to have data for reimbursement. You don't get paid if you don't have that data, ,but there has been a lack of the government winding up saying you have to have data to meet these quality standards for care. That is what I thought that they were asking for here.
Margaret, do you have the same impression?
MS. AMATAYARUL: Yes.
MR. BLAIR: So, that, I think, is broader than practice -- I think that what you are indicating there is a subset of the breadth of what they were asking for here.
DR. FITZMAURICE: And you might phrase it as requirements for quality of care data reporting. I mean, that is a little strong, given that there may not be national consensus on what the D, quality of care measures, should be. One could start with HEADUS and work up and work down.
MR. ZUBELDIA: How about the government should adopt standard terminologies that support the quality of care reporting?
MR. BLAIR: This was a different thing. This was winding up saying that there would be incentives in place for quality, health care quality and in order to meet -- in order to meet those standards for quality, you had to have information and the third level down is in order to have that information, you would have to have clinically specific terminology.
So, it was at a very high level of incentives to drive forward clinical terminology but up through the path of quality instead of up through the path of reimbursement.
MR. ZUBELDIA: Jeff, isn't that outside of the scope of what we need to do? I think that is too high a level to push it.
DR. COHN: For me, I think, the big issue I have with this is that many clinically specifically terminologies that I can think of require a computer-based patient record to actually make work. I mean, most clinically specific terminologies, you can't handle on an encounter form, sort of by definition.
Knowing the state of the marketplace out there, what we are trying to do is to incent increases of standards, increased computerization, but I don't know that we are at a place where we could actually put something in place. Now, I think the way it is right now, which is evaluation of requirements is probably appropriate. But that is a whole lot different than saying we are going to start putting those out there and require people to start responding to those requirements.
DR. FITZMAURICE: I think you are right, Simon, but I would introduce the point that as we move toward greater quality, as we move toward reducing errors in medicine, there ought to be an investigation of the link between the data recording by clinicians, the terminologies out there, the practice guidelines or the rules by which clinicians agree that they want to practice medicine, the clinical performance measures that result from that, how does that link with the terminology they use in recording information about the patient?
So, I am looking at this as an investigation, not as a government mandate to --
DR. COHN: Isn't that 20?
DR. FITZMAURICE: Yes, that is part of it. It is 20.
DR. YASNOFF: It is a little bit more specific than 20.
MR. BLAIR: Okay. So, we could put those together.
DR. FITZMAURICE: We could mush them together and we can wordsmith the mushing later.
MR. BLAIR: So, you are on B now, right?
DR. YASNOFF: Now we are on B. The government should establish minimum data sets and requirements to report on compliance with quality of care standards. That is the same as A.
DR. FITZMAURICE: I would say work with the private sector to develop minimum data sets. Instead of quality of care standards, quality of care measures.
MS. GREENBERG: You are linking that to the scope of patient medical record information by saying -- it seems to go beyond it. I understand you are doing this in a way to try to create better incentives, but -- it seems to me a little beyond the scope of what you are doing here.
DR. COHN: I guess I would speak to having us strike B, period.
MS. GREENBERG: I would say the same thing about -- yes, did you say B and C?
DR. COHN: I hadn't gotten to C yet.
MR. BLAIR: Before we do anything with C, I would like to know what C means. I don't understand what that is.
MR. BLAIR: Margaret, can you help us?
MS. AMATAYARUL: The government should adopt a standard data dictionary for reporting of existing public health functions. There were several people that were very concerned that you report to one government agency using this set of terms and their associated meanings and not only within government, but also the private sector reporting requirements, but --
DR. MC DONALD: Does this relate to that one hearing we had where we had the public health hearing or is this -- there was a lot of discussion.
Well, the word "data dictionary" is so vague, I am not sure what they are really asking for. Is it asking for physicians to type in stuff that is coded so that the public health can use it?
DR. YASNOFF: No.
The way this is stated just does not make sense to me. I don't understand what this is. So, I can't comment on whether it is good or bad.
DR. FITZMAURICE: Let me play Bob Mayes for a second and say that what might be useful is to have a registry of the data dictionaries used by the various public health departments and to investigate the commonality of terms and of their definitions.
DR. MC DONALD: Are you talking about terms or fields?
DR. FITZMAURICE: I am talking about terms,
but --
DR. MC DONALD: Because data dictionary usually means fields in a database, which is sort of the place where you store the data or the terms.
DR. FITZMAURICE: All right. Then, yes, it is an inventory of their data sets and the definitions of the data.
DR. COHN: Well, you know, if I can just make a comment, I would almost turn it the other way around, which would be that if we were to even make a recommendation in this -- and I am not sure that I even agree with anything here is is that public health ought to be using the data registry that is being developed as opposed to us investigating their data registries.
MR. BLAIR: I would second that. I don't think you want to undertake that investigation. I think it would be very depressing.
DR. MC DONALD: Bill, are you there?
DR. YASNOFF: Yes.
DR. MC DONALD: This is talking about public health. So, what do you think -- what is this really for?
DR. YASNOFF: Well, I don't know. That is what I am trying to get at because as it was worded, it doesn't mean anything to me.
DR. MC DONALD: Well, if you don't know, I don't think I can support it if it is for public health.
DR. YASNOFF: I don't know what it means. But if what you are trying to say is that public health should adopt standards for reporting of patient -- uniform standards -- uniform accepted standards for reporting patient medical record information for public health purposes, that is a recommendation that makes sense. I am not sure this is where it should be. But that makes -- I understand that. That makes sense.
DR. MC DONALD: I can support that one, too.
DR. YASNOFF: I am not sure that that is what this is -- I don't know if that was the intent of this or if it was some other intent.
MS. AMATAYARUL: Could you please repeat what you just said as a recommendation and then we will find a place to put it?
MS. GREENBERG: Well, does it even belong here? I don't know.
DR. FITZMAURICE: Well, it belongs somewhere probably and it is --
DR. YASNOFF: Public health should utilize existing -- what are we calling --
DR. FITZMAURICE: Terminologies.
DR. YASNOFF: -- existing terminologies for reporting PMRI for public health purposes.
DR. FITZMAURICE: Collecting and reporting?
DR. YASNOFF: Collecting. Yes, collecting. To collect.
DR. COHN: What does that mean, though?
DR. YASNOFF: That means that if we want to collect information about public health, if providers --
DR. COHN: What does "existing terminologies" mean?
MS. GREENBERG: Yes. Exactly.
DR. FITZMAURICE: SNOMED, MEDCIN.
DR. COHN: There are a lot of existing terminologies around.
DR. YASNOFF: Standard. Standard terminologies? What --
DR. COHN: I will buy that.
MS. GREENBERG: It seems to me what you are trying to -- I mean, what is being -- maybe I am wrong, but people are saying that there are different requirements for reporting on quality of care. There are different ones all over the place. There isn't -- so that this creates a burden and no consensus on what should be reported. Public health also asks for data in all different types of formats, et cetera.
Those are major problems, but I don't know that they really are ones that should be addressed in this report. The quality of care ones are probably -- might be addressed by the Work Group on Quality. And maybe there is some coming together on that.
I mean, the whole issue of -- if you are talking about the whole issue of the need to integrate public health data systems, that certainly is something that is well-recognized and there is some work going on there. But exactly how it -- how you would derive that from this, I am not quite sure.
DR. FITZMAURICE: We may derive it from the testimony. Maybe we would derive it from published articles and professional opinion of the National Committee.
MS. GREENBERG: Well, but I mean does it relate to coming up with recommendations for standards for patient medical record information and its transmission? I don't know.
DR. YASNOFF: I think it absolutely does because the -- one of the key purposes of communicating patient medical record information is for public health reporting. So, it is an incentive and what I think we don't want is we don't want public health to invent HL8.
PARTICIPANT: Right. For reporting.
MS. GREENBERG: Oh, I would agree with that.
DR. YASNOFF: I think that is why we need to say this and we want public health to use existing terminologies and message formats for reporting and that is a way for the government to encourage the wider use of these standards. But I am not sure that belongs in this spot.
DR. COHN: Maybe we should add message formats in there, too.
MR. ZUBELDIA: I am wondering if we should have a listing of uses of these terminologies, the same as in the administration publication side, there is the nine transactions that have to be adopted. Maybe on the make a record side, we should have a listing of users to make sure that the terminologies adopted satisfy these users and public health is one of them.
Maybe we should keep track of those users that we find to create such a listing.
DR. YASNOFF: I agree with that, but I think -- I just want to point out and, again, this does go back to the testimony we got with respect to surveillance, that for surveillance transactions, typically it is public health that is going to be responsible for defining those transactions. No one else really has a need for exactly the type of transaction that public health needs. But it should be within the framework of, say, an HL7 and it should use standard terminologies, like SNOMED.
MR. BLAIR: Are we close enough on this discussion, on this item, that -- or is there some other major concern about it that we need to modify?
MS. GREENBERG: Some public health reporting may not be at the terminology level, like SNOMED. You know, I think this is pretty much of a leap.
DR. COHN: I guess this certainly doesn't -- we are talking about evidence-based medicine and then we jump to public health. Public health is a type of evidence-based medicine but it is usually -- I mean, it is actually sometimes specific, but often times is lumped together. So, it should be somewhere.
DR. YASNOFF: Well, the reason we got into this and I want to ask the question, again, of you, Jeff, is I want to be sure that we are capturing whatever it is you meant in here -- and Margaret, you, too, when you said the government should adopt a standard data dictionary for reporting of existing public health functions.
MR. BLAIR: That is a different line item and on that one, I just did not hear a lot of support. Nobody seemed to know what that really meant.
DR. YASNOFF: I still don't know what that means. But if it means something, I would like to know, so that we can decide how we can express it clearly.
MR. BLAIR: Margaret, unless there is some other clarification you could add from, you know, how you came up with that --
MS. AMATAYARUL: I think that the suggestion for the recommendation that public health should utilize standard terminologies and message format standards for collecting or reporting PMRI for public health purposes is the intent of that.
MR. BLAIR: Okay. So, then we could strike the data dictionary comment?
MS. AMATAYARUL: Yes.
MR. BLAIR: Do you all accept that?
PARTICIPANTS: Yes.
MR. BLAIR: Okay. Let's move forward.
DR. YASNOFF: I just want to not forget the point that I don't -- I agree with Simon that I don't think that this recommendation necessarily fits in this spot. We are going to deal with those issues later.
MS. AMATAYARUL: I have got a note to move it.
DR. FITZMAURICE: And likewise with B, I would like to have a rewording of that and include that in a different spot.
DR. MC DONALD: Rewording of what for that?
DR. FITZMAURICE: B is the government should establish minimum data sets --
DR. MC DONALD: Okay.
DR. FITZMAURICE: -- in compliance with quality of care standards.
DR. COHN: No. I actually don't think that that should be -- I mean, if you want to bring it up as another proposal, that is fine, but I would be against them establishing minimum data sets.
DR. FITZMAURICE: Agreed. That is why I would like to have it reworded.
DR. COHN: Oh, okay. We are getting rid of then. Okay.
MS. AMATAYARUL: Do you want a reword or -- I have already struck it.
DR. FITZMAURICE: I would reword it so that the government should work with the private sector to develop minimum data sets and reporting requirements for quality of care measures.
DR. MC DONALD: Are you able to type that fast that you capture that?
MS. AMATAYARUL: No.
DR. MC DONALD: Should he repeat it one more time so you got it down?
DR. COHN: I guess I am getting real -- I mean maybe it is getting to be 5:21 or something like that, but I can't for the life of me what that has to do with medical terminology issues.
DR. FITZMAURICE: But it has to do with evidence-based medicine and linking what goes in the patient record back with the evidence base. Do the quality measures relate to the evidence base? We certainly hope so. Are the measures in the record? Are they in the terminology that can be uniformly applied? Can we measure anything about quality without uniform terms? So, linking that to the evidence-based medicine on the left hand side.
MS. AMATAYARUL: Can you repeat what you said, Mike?
DR. FITZMAURICE: This may even need to be reworded again, but the thought is the government should work with the private sector to develop minimum data sets and reporting requirements for quality of care improvement measures.
MS. AMATAYARUL: Do develop minimum data sets and what?
DR. FITZMAURICE: Minimum data sets for reporting on quality of care improvement measures or quality of care measures.
DR. COHN: Isn't that NCQA?
DR. FITZMAURICE: Given some time, I can think of a better word that one. But the sense is that what is in the patient medical record ought to relate to the terms used in evidence-based practice of medicine. The link there is in terms of getting information for quality of care, feeding it back to people who are doing the care providing.
DR. COHN: I don't want to beat this up anymore, but I do think that that is 20.
MR. BLAIR: You think what?
DR. COHN: I think that that is 20 again, Item 20, about secondary uses -- but I will let Margaret decide on that one.
Shall we move on?
MR. BLAIR: Yes.
MS. AMATAYARUL: No. 24. Many testifiers observed that medical terminologies are evolving to support evidence-based medicine. Even after medical terminologies that support evidence-based medicine are more accepted, virtually all testifiers felt there will continue to be an important need for mapping back to terminologies required for statistical and reimbursement purposes.
The recommendations are the government should continue to support the National Library of Medicine, as it maintains the UMLS as a meta-thesaurus and the government should recognize that the business use should determine the terminology to which data may be mapped.
DR. MC DONALD: I think you have four different sort of thoughts. There are two under the issues and two under the recommendations. I agree with all of them, but I don't know how they are connected.
DR. YASNOFF: I just want to make an important editorial change in A. NLM maintains the UMLS and the meta-thesaurus. They are not the same thing. Thank you.
MR. BLAIR: Okay. Any other refinements?
MS. GREENBERG: I am a broken record here, but basically it is classifications that are used for statistical and reimbursement purposes not normally terminology.
DR. COHN: I guess I am -- like Clem, I sort of think that there are actually a number of things that are put together on this one. To me, the important piece
is --
DR. MC DONALD: Simon, could you talk a --
DR. COHN: I am sorry. I agree with you, Clem, that there are a number of different concepts put together here. To me, the big issue here, though, is the term "mapping" and to me, the recommendation here is that the government needs to be taking a lead on mapping and it is a major requirement and a major issue. Now, what I would comment about here is is that I actually don't completely agree with A, which is the government should continue to support the NLM and maintain the UMLS and the meta-thesaurus.
I think that the -- to my view, the UMLS and the meta-thesaurus need to evolve to become a more robust mapping -- have more robust mapping capabilities, which includes things, such as rules-based mapping logic and things like this, which I don't believe it supports right now.
So, yes, it needs to do all this, but it needs to evolve to better meet these needs.
MR. BLAIR: Could we add that --
DR. COHN: I think she is actually adding it right now, I hope.
DR. MC DONALD: Again, I am sorry. I couldn't quite hear all that. You are saying we shouldn't support A or we should add something to it?
DR. COHN: I think it needs to be more than it is. I said basically that the UMLS needs to evolve to become more robust in terms of its mapping capabilities.
DR. MC DONALD: I don't think I would want to say that in this.
DR. COHN: You wouldn't want to say that?
DR. MC DONALD: Well, you are actually saying that it is no good and you have to support that --
MR. BLAIR: He didn't say it is no good. He is saying to make it stronger, to enhance it.
DR. MC DONALD: I am saying if you say it needs more robust mapping, it is the same as saying it is not robust. I think you either need a paper to support that or you need -- I mean, I don't think you want to throw stones that way.
In another bullet we would explore newer kinds of mapping, you know -- we should find a safer way to say it.
DR. COHN: Well, Clem, I think that maybe what we need to do is we need to ask Betsy Humphries for her opinion on this one. I am just trying to get the idea on the table and I am not -- this is not intended to throw stones at the UMLS, which I think is wonderful. It is just that it needs to get better.
Now, I guess the other question I have here is what the recommendation is that is C, which it says the government should recognize that the business use should determine the terminology to which data may be mapped. I think I agree with that comment, but I don't know that it is particularly a recommendation.
PARTICIPANT: Not very actionable.
DR. COHN: Yes, I don't -- I, of course, agree with this, but I don't know what to do with it.
MS. AMATAYARUL: Maybe this is more of an issue.
DR. MC DONALD: No, actually, it is a nice statement. If we could say the government's policies will recognize or the government will not make policies that don't -- you know, something like that.
DR. COHN: Well, I actually -- you know, I had made notes to myself before and perhaps, you know, once again, we need to decide how this play out. This is potentially an important area, but if we, for example, were to decide that there were candidate terminologies that we either think ought to be national standards or close to it or whatever, certainly I think a requirement ought to be that these things be well mapped within the UMLS. Anything that gets even close to becoming a national terminology ought to be mapped.
So, I don't know if that is a business use or a business need, but that is certainly a policy statement.
MS. AMATAYARUL: Is that a guiding principles?
DR. MC DONALD: I like that, Simon.
DR. FITZMAURICE: You can do the mapping but can people use it? These code sets are or these terminologies and classifications are proprietary. There needs to be not only the ability to do it, but also the ability to make a business use of it and that gets involved in the licensing.
So, should NLM take a role in facilitating the use of it? I don't know. But that would be certainly what has to come next. Otherwise, it won't be driven any further than an academic exercise.
MS. GREENBERG: It seems the mapping would have to be in the public domain.
DR. COHN: I guess if the ULMS was doing it, one would hope that the mappings were in the public domain. Though, likely people would have to have licenses to vote other terminologies to be able to utilize the mappings.
DR. FITZMAURICE: If there were national license -- and we might want to make a recommendation about national licensing or investigating that possibility, as opposed to every user has to go out and start negotiating with SNOMED or negotiating with CPT.
DR. COHN: For mapping or for the licenses themselves.
DR. FITZMAURICE: For making use of the mapping -- for making use of the mapping in their business purpose.
MR. BLAIR: That is a major issue.
DR. FITZMAURICE: You can put my terminology up there. You can freely use it for research, but when you start making a buck from it, I want half a cent.
DR. COHN: Well, I guess, I need to clarify because I may be a little confused. Are you referring to national licenses of the terminologies or just of the mapping between the terminologies?
DR. FITZMAURICE: Of the terminologies. I mean, you can map -- you can lead the horse to water, but then you say you can't drink with it unless you get a pound of gold.
DR. MC DONALD: You are doing good, Mike.
DR. FITZMAURICE: Thanks, Clem.
MR. BLAIR: Does that need to be part of this issue? Because I think that that kind of stands alone as an issue, is the people still have to pay to use the terminology, as long as the mapping is there -- do they have to be tied at this point or what do you think?
DR. FITZMAURICE: They can be entirely separate, but it is recognition that that is an issue that -- do we want the government to invest in something that stops the horse from getting to the water? Or do we want to say this is also a problem we need to have the horse drink the water, too, and there needs to be some facilitation or at least recognition that this is a problem.
MR. BLAIR: Doesn't that belong in 13? All the issues related to cost and affordability and so on?
DR. FITZMAURICE: Reference 13 on that.
DR. YASNOFF: I don't know if this is the right place for this, but I think we need to have a recommendation with respect to guidelines. I mean, we are talking about evidence-based medicine. I guess maybe I am a little bit behind. Maybe this belongs in the last bullet. But I think we need to make a recommendation about facilitating standards for sharing and dissemination of guidelines.
DR. COHN: You are right. It isn't here, I don't think. It is somewhere else probably.
What would that look like to you?
DR. YASNOFF: There are some evolving -- I mean, there is no standard to recommend, but something to the effect that the government should encourage the development of interoperable standards for dissemination and sharing of guidelines in computable format.
DR. FITZMAURICE: I am not sure if that is patient medical record information or not, but it might be. The rules -- I mean, based upon those guidelines are certainly used in such systems.
DR. YASNOFF: Several of our testifiers said that they thought it was and that -- and also recommended that the government promote standards in this area.
DR. FITZMAURICE: I certainly would like to see the government do that.
DR. YASNOFF: And I think it is a good thing to do.
DR. FITZMAURICE: I think it is a good thing to do as well.
DR. YASNOFF: I am already working on it so it doesn't require any new activity for the government to do that.
MS. AMATAYARUL: Is that what we were trying to get at in No. 23?
MS. GREENBERG: I think so.
DR. YASNOFF: I think that probably fits in better with 23. And I apologize.
DR. FITZMAURICE: It is a very good adjunct to 23.
[Multiple discussions.]
-- standards needed to actively link the guidelines with what is in the medical record.
MR. BLAIR: Does the silence that we have agreed on --
DR. COHN: I want to see it written and where it is, but I am willing to go on.
MR. BLAIR: We are finished with 24.
MS. AMATAYARUL: 25. Several testifiers identified that terminology development processes need to be sufficiently flexible to be responsive to changing needs of a dynamic clinical environment.
A is the government should adopt guiding principles for PMRI medical terminologies that recognize the need for flexibility to accommodate changing needs in health care.
And, B, the government's time line for adoption of medical terminology standards should be prospective and a transition period to the new standards must be lengthy enough to allow everyone to move to new systems without incurring undue hardship.
DR. COHN: What does this recommendation mean?
MR. BLAIR: Which one, A or B?
DR. COHN: Well, actually I understand what A is. But what does B mean?
MS. AMATAYARUL: Go slow.
MR. BLAIR: Especially with respect to the timeframe for the implementation because -- at least this was my understanding when you were reading it to me -- this is saying that especially with terminologies even more than with message formats, as you could tell, it may take six months, nine months, a year, to implement a medical terminology -- a message format standard. Okay?
But medical terminologies here, if they are going to become part of the data dictionary and electronic health record, that may take a year and a half, two years, three years. It has to go into vendor systems before it could even be user systems and it just -- and during that time, things could change.
So, this was just -- at least my understanding was that this is saying a special caution needs to be put in place with any recommendations we come up with for medical terminologies in terms of how quickly they are to be implemented.
Did I capture that correctly, Margaret?
MS. AMATAYARUL: Yes, I think so. As I recall, I think this was actually Dr. Jesse's(?) specific recommendation.
DR. FITZMAURICE: I guess I don't see this as being a recommendation so much as what would follow a recommendation that the government should adopt MRI medical terminologies and then we would qualify it by --
MR. BLAIR: Yes, you are right.
DR. MC DONALD: Jeff, could I just clarify a little bit?
MR. BLAIR: Yes.
DR. MC DONALD: There is another difference and that is that although -- it usually takes longer to get a message standard out than an additional add-ons to a vocabulary.
Well, I mean, the thing is we have vocabularies -- ICD-9 does them once a month, don't they? There are examples. Or one of the HCPCs, they have a regular meeting every so often. The opposite issue is that the vocabularies aren't done as a big ballot, as a big bloc, as a total unit. They are continually updated maybe every month, every six months, but they are going to be
-- ordinarily have to be new diseases come out, new bugs come out, new --
PARTICIPANT: Right.
DR. MC DONALD: So, there is also a greater dynamism to the vocabulary. It is more fast --
MR. BLAIR: You know, Clem, that is a very valid point that once the vocabulary or terminology is implemented, it has to be updated quickly and promptly to reflect those changes. I think we were thinking of getting the infrastructure in place for the first time.
DR. MC DONALD: I don't disagree with anything said and I think the recommendations are fine, too.
DR. YASNOFF: Jeff, should we capture that particular statement somewhere that terminologies that are adopted need to have an accompanying system for continuing regular updates? Do we need to say that?
MR. BLAIR: Well, yes, we certainly could and I think that the point about the flexibility -- the flexibility means that it needs to be able to be updated quickly and without any architectural impacts. Yes. Did you want to add that phrase? I think you are in a better position to work with Margaret.
DR. YASNOFF: Yes, I think that needs to be added. I am not sure -- it is probably one of our guiding principles.
MS. AMATAYARUL: It is actually -- it is one of the criteria in the characteristics and attributes.
DR. YASNOFF: Oh, it is already there?
MS. AMATAYARUL: Yes.
DR. YASNOFF: Okay. Well, good.
MR. ZUBELDIA: Should we also specifically state that the standard implementation timeframe of two years or three years for small plans that applies to the rest of HIPAA doesn't apply to terminologies?
MR. BLAIR: I don't know if we should make a blanket statement like that, but I think we are leaning in that direction.
MR. ZUBELDIA: It may not apply to terminologies. It may apply to formats, but not to terminologies.
DR. COHN: I guess if I can just ask -- and this is going back to the issue of under what circumstances are we mandating? Are we telling everybody that they need to stick them in? Or are we telling people that they need to send things around and about if they have a system that does X, Y and Z, they should implement this terminology at a certain point?
What exactly does this mean? Having said that, let's hold that thought and mull about it as we look at it again.
Marjorie.
MS. GREENBERG: You seem to be talking about several different things, but one is -- I mean, I liked the way Mike rephrased it because I don't -- unless you think that the government should adopt a specific medical terminology standard for patient medical record information --
PARTICIPANT: Or several.
MS. GREENBERG: It wasn't clear to me that you were going to recommend that. But that is the way the recommendation sounds. Maybe it is just -- when terminology standards are adopted, they should be, you know --
DR. FITZMAURICE: We are talking about implementation issues but first there is a recommendation to do something.
MS. GREENBERG: And then you have got the other issue, as you said that once something has been adopted, you have to be able to change it. Doesn't HIPAA make that distinction? The standards can only be updated once a year, but it makes a distinction on the code sets. It can be updated more regularly. It is agreeing with that. You just need a process that will allow it.
MR. BLAIR: So, are we winding up with a wording change on this? Gary, did these other comments fit in with your suggestion?
PARTICIPANT: Who?
MR. BLAIR: Bill, yes.
DR. YASNOFF: What were the comments again? I wasn't --
MR. BLAIR: I wasn't sure whether we have changes to this or --
MS. AMATAYARUL: I have got when the government adopts medical terminologies, it should do so in a time line that is prospective and a transition period to the new standard must be lengthy enough to allow everyone to move to new systems without incurring undue hardships. Standard timeframe for compliance of two years may not apply to terminologies.
DR. YASNOFF: By "may not apply," do you mean may not be long enough?
MS. GREENBERG: Do you really want to include that? Because is there anything that indicates it has to be two years, the patient medical record information?
DR. FITZMAURICE: Yes, I guess I would delete length of time because there is no basis for it.
MR. BLAIR: How about saying lengthy enough to avoid undue hardships or why don't we say lengthy enough to reflect the difficulties in implementation?
No, that is negative, huh?
[Multiple discussions.]
DR. YASNOFF: -- and it is very non-specific and we are also -- by saying avoid undue hardship, we are essentially saying, yes, we know there is going to be hardship here. It is just we are going to try to make it tolerable.
DR. COHN: Are you saying in each case, you mean, or --
MS. GREENBERG: I don't know. I don't know what you are thinking of adopting.
MR. BLAIR: Tell you what, Michael, why don't you address that to our group as a whole.
DR. FITZMAURICE: Is there a sense that we should order pizza out and continue working through the night or that we should set a deadline that will allow people to go out and get something to eat, like 6:30, 7 o'clock. I am just trying to anticipate -- Bill alerted me to the fact that some people still eat in these days.
Some people may have dinner plans and prefer to have something else in Washington. So, either we set a time or we would order in.
MR. BLAIR: Simon, what is your preference? Which way would you rather go?
DR. COHN: I don't have a strong feeling. It is only 5:30 -- 2:30 California time.
PARTICIPANT: That is not fair. Simon is not hungry.
MR. BLAIR: My perception is that we are starting to gain momentum. We are seeming to move more quickly now and it is possible if we went for one more hour, we may be able to --
MS. GREENBERG: They are trying to indicate something to us. I don't know that they are prepared to stay all night here.
MR. BLAIR: Why don't we take a two-minute break and we can discuss -- we don't have to discuss this on the Internet.
Clem, are you still attached, though?
DR. MC DONALD: I am still attached.
[Whereupon, at 5:45 p.m., the meeting was recessed, to reconvene at 8:30 a.m., the following morning, Friday, December 10, 1999.]