[ThisTranscript is Unedited]
Hubert H. Humphrey Building
Room 705A
200 Independence Avenue
Washington, D.C. 20201
DR. LUMPKIN: We are going to get started. Before we do introductions, I just want to talk a little bit about the agenda and then we will go and have introductions.
We were just informed -- I know they live in different cities but maybe Denise Koo has the same bug that Ted does. Now, I did get my flu shot. So, maybe I am protected. There is now adequate flu vaccine for anybody who still has their doubts.
So, Denise Koo will not be able to be here and that is unfortunate. Hopefully, we can get her to come to our next meeting because this is a very important piece of -- a very important development that she has been working on and one which fits into many of our standards work from process to bridge and certainly is important for standards related to non-transactions. So, we will hope to put that on our agenda.
The other thing is is that on the schedule is that when I got in late last night, I was listening to the weather report, as many of you have, and I know that there is a bit of a concern by a number of people. So, we will not -- we will move everything up. My proposal would be is that we would not have lunch, that we would -- after we have our presentation on ICD-10, that we will begin to have committee reports, take motions, vote things through and when we are done, we are done, and we not take a break.
Any disagreement with that? Okay.
Let's go around with introductions and then we will have our first presentation.
My name is John Lumpkin and I am director of the Illinois Department of Public Health and chair of the committee.
Let's start with Simon.
DR. COHN: Thank you, John.
I am Simon Cohn. I am a member of the committee. I am the national director for health information policy for Kaiser Permanente.
MR. SCANLON: I am Jim Scanlon from HHS, ASPE. I am the executive staff director for the committee.
MS. COLTIN: I am Kathryn Coltin from Harvard Pilgrim Health Care, a member of the committee.
DR. FITZMAURICE: I am Michael Fitzmaurice, Agency for Health Care Research and Quality and liaison to the National Committee.
DR. LENGERICH: Gene Lengerich from Penn State University and member of the committee.
MR. ROTHSTEIN: I am Mark Rothstein. I am the director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine and member of the committee.
DR. MAYS: Vickie Mays, University of California, Los Angeles, member of the committee.
DR. FRIEDMAN: Dan Friedman, Massachusetts Department of Public Health, member of the committee.
MS. FYFFE: Kathleen Fyffe, Health Insurance Association of America and a member of the committee.
DR. STARFIELD: Barbara Starfield, Johns Hopkins University and member of the committee.
MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, and executive secretary to the committee.
DR. NEWACHECK: Paul Newacheck, University of California, member of the committee.
DR. LUMPKIN: Great. Thank you.
ICD-10-CM. We are all waiting with baited breath.
MS. PICKETT: That is good to hear.
DR. LUMPKIN: It is more of a statement about us.
MS. PICKETT: Good morning. Thank you for inviting NCHS to present an update on ICD-10-CM to you this morning.
For those of you who have seen some of this presentation before, we apologize; however, there are several things that we wanted to bring everybody up to date on in terms of the development and status of ICD-10-CM.
The first slide is just an historical overview of the history of ICD and the various implementations and revisions that have occurred over the last 100 years. In January 1999, the United States started to use ICD-10 for mortality data. So, we are now in the second year of using ICD-10 for mortality.
There are some major revisions to this version of ICD and some of those major changes were actually field tested by WHO prior to its implementation. The three major chapters that have changes are the mental health chapter, Chapter 5, Chapter 19, injury poisoning, and Chapter 20, the external causes of injury.
As of October 1999, and this is the latest information that is on the WHO web site, ICD-10 has been published in 37 languages and has been implemented in 60 countries for morbidity and/or mortality. Again, the United States began using ICD-10 for mortality in January 1999.
Several countries use ICD-10 or a clinical modification of ICD-10 in case mix and reimbursement systems. Here is a short list of some of the countries that are already using ICD or, again, its clinical modification for case mix and reimbursement.
Some of the years are missing because we have a lot of information that we are still gathering about the use of ICD-10 for case mix and DRG-based reimbursement. But this gives you an idea of how things have progressed since the implementation of ICD-10.
ICD-10 represents the broadest scope of any ICD revision in the last 100 years. Changes include a move to alphanumeric codes instead of the current numeric character structure. Again, certain chapters have been restructured. There have been some new features added to the ICD and new terminology and clinical concepts have also been added. Again, this is the WHO version.
Expansion of detail, there are approximately 850 more categories in ICD-10 than there were in ICD-9 and there is now an international updating process for ICD-10. This is extremely significant. Prior to ICD-10, there were no revisions to the international version between the major revisions. So, any new diseases or new knowledge about disease entities was not incorporated into the classification until the next major revision.
Of course, many of you probably know, here in the United States, where we were actually using ICD-9-CM, we do have an annual update process. So, for our national purposes, we were updating and including new diseases and newer information. But at the international level, that was not occurring until this version of ICD-10.
Again, it is an alphanumeric structure. The leading character is alpha and all of the alphabet is used from A to Z. Injuries was restructured and that is a major restructuring of the classification. In ICD-9, the axis for the classification was by type of injury. In ICD-10, the major axis now is by site of injury with the second character of the three digit rubric indicating the site of the injury and the third rubric of the injury code indicating the specific type of injury.
Risk factors to health have been added to the classification and this is a new feature. So, there are many more codes now that identify various issues; inappropriate diet and eating habits, Type A pattern behavior, lack of relaxation and leisure, something I am sure some of us will kind of know a little something about. Occupational exposures to dust and other problems are also available for other occupational exposures.
Again, these are features that are new to ICD-10. For diabetes, there has been a change in the axis and their categorizations have changed. In ICD-9-CM at the fifth digit level, you could identify whether the diabetes was juvenile onset or adult onset. In ICD-10, WHO has changed and expanded the code so now that you have specific codes for insulin dependent, not insulin dependent and malnutrition-related -- and, again, these are their own three digit codes and they do expand further out at the fourth digit level.
The external causes of injuries has been restructured and also expanded. All of the external causes of injury codes previously existed in E800-E876. You now have all of the external cause of injury codes from V01 all the way to Y84; so, a very large expansion there to accommodate greater level of detail.
In 1994, NCHS awarded a contract to evaluate ICD-10. The primary purpose was to assess whether ICD-10 was a significant improvement over ICD-9-CM to warrant implementation for morbidity reporting. The evaluation contract was also to recommend additional improvements to ICD-10 and to correct any problems that were identified during the course of the evaluation.
As part of the contract, they also developed an expanded alphabetic index and a crosswalk to ICD-9-CM. Contract findings were that ICD-10 was not significantly better than ICD-9-CM for morbidity applications, but that a clinical modification to ICD-10 would be a significant improvement and worth implementing.
Again, one of the reasons explaining that would be that, again, as I indicated, ICD-9-CM has been updated annually since 1985. So, a good number of changes that have found their way into ICD-9-CM had not found their way into ICD-10 as published by WHO because of the timing factor. Clearly, when they completed their work on ICD-10, 9-CM was still being updated. So, there was at least another four or five years of updates in 9-CM that were not in ICD-10.
Also, why a clinical modification? That is a question that does come up quite frequently. There are a number of users of the classification that had expressed to NCHS over the years that there was not enough detail in the classification for use in ambulatory care and managed care encounters. There were emerging diseases and other recent medical knowledge that also needed to find its way into the classification.
There are codes in ICD-10, which is basically a mortality-based classification, although it is used for morbidity. There are a number of concepts that are in the classification that are very specific to mortality and don't have any usefulness in terms of morbidity applications. So, there is a need to remove those things.
There are procedure codes in ICD-10. There is no international classification for procedures. So that some of the procedure information that WHO needs to capture information on are actually identified as codes in the diagnosis classification. Those things were also removed, feeling that a diagnosis classification should be exactly that, a diagnosis classification and that procedure concepts should be captured in a procedure classification or code set.
Then there is a convention used in the ICD called the dagger/asterisk convention. The dagger code is your underlying etiology and your asterisk code is your manifestation. This is a convention that is used by WHO, where you always need two codes to report pretty much every condition in the book.
In ICD-9-CM, we did not implement dagger/asterisk. Instead we created combination codes that brought the two together into a single code. So, in ICD-10-CM it was felt that we would need to repeat that. Otherwise, you would be disaggregating the data and making it more difficult to identify conditions that you used to be able to identify with one code in ICD-9-CM and would require two codes if you use ICD-10, as published by WHO.
In creating the clinical modification, we also looked at other uses of the classification beyond your traditional in-hospital setting for its use. We also evaluated residual categories. There is a code that is called other specified -- for those who are familiar with the classification, it is usually at the .8 and includes a lot of conditions, which many clinicians feel needed to be broken out for that additional detail.
So, we reviewed all of those categories to see where there was an opportunity to actually expand the classification and provide more detailed clinical information. We also undertook a review of the minutes of all the previous ICD-9-CM coordination and maintenance committee meetings. Again, we have been meeting since 1985. Minutes are generated from all of those meetings and very good ideas have come across from the users of the classification, many of which could not be included in ICD-9-CM because of the structure of the classification.
Many of the codes in ICD-9-CM were already at the limit of a five digit code. The four digit sub-categories are already in use and there is no ability to expand out. So, while some of the ideas were excellent, there was no way to include some of those concepts in ICD-9-CM.
So, in going back and reviewing the minutes, we wanted to look at what those things were that we could include in ICD-10-CM. We also worked with a number of physician groups and others to ensure clinical accuracy and the need for more clinical detail. And this, again, is a short list. Yes, it is a very short list of some of the groups that we have worked with in making refinements to ICD-10-CM.
Between December 1997 and February 1998, we had an open comment period. The tabular list of ICD-10-CM, the draft at that point in time, was placed on the Internet and we invited public comment. We received approximately 1,200 comments from 22 organizations and individuals and these are organizations or individuals who were not originally part of the groups that provided input in the creation of the first draft or the second draft of ICD-10-CM.
So, where are we? You might ask about where are with ICD-10-CM. The major modifications that have been made to ICD-10-CM include the addition of a sixth character, the addition of laterality information. Again, we have combined the dagger/asterisk codes, which, again, was a carryover from ICD-9-CM. We have created many more combination codes for diagnosis and symptoms. We did deactivate the procedure codes and more recently we have added code extensions for injuries and external causes. And I will give you examples of that in just a moment.
We have also added trimester information to the OB codes. The current fifth digit designations in ICD-9-CM have been deactivated. We have revised the diabetes codes. We have expanded completely, well, not completely, but we have done a great job in expanding the injury codes and we now have full code titles in the classification.
An example of the combination codes for diagnosis and symptoms, we have created codes, for instance, in the first example for atherosclerotic heart disease with unstable angina. Currently, that would require two codes in ICD-9-CM. It happens frequently enough and the requests have come in to have one code that describes that as opposed to using the two codes. There is a combination code from Crohn's disease of the small intestine with intestinal obstruction and acute prostatitis with hematuria.
Again, these are just examples of how we have taken situations where two or three codes that might have been used previously in ICD-9-CM to describe these conditions and created unique codes that describe all of the information in one code.
For the OB codes, where we have added trimester information, this example shows you how we have added that and, again, the information is only added where it is clinically valid so that you don't have someone trying to create a code that would be completely invalid, where, for instance, eclampsia in pregnancy is not an issue at certain points of the pregnancy. No code exists for that.
The diabetes categories that WHO created have been revised to reflect the diabetes classification that was published by the ADA in 1997. Again, the diabetes fifth digit codes that are in 9-CM will not be used in ICD-10-CM.
This slide gives you an example of the expansion. The ICD-10 codes are shown on the left and then the ICD-10-CM codes that are consistent with the ADA classification are shown on the right. Keeping in mind, however, we do have to be able to collapse back to ICD-10 and we are able to accomplish that even with the expansion.
The injury codes in ICD-9 and ICD-10, under open wounds, for instance, you have a number of situations that are described under the rubric "Open Wounds," and that includes laceration with foreign body, without foreign body, puncture wounds with and without foreign body and bites.
Under "Superficial Wounds," you have abrasions, blisters, contusions. You have a number of things that are classified to superficial wounds. What we have done in ICD-10-CM, we have actually expanded the codes so that you can identify an abrasion as opposed to an abrasion being brought up into a superficial wound.
So, the code tells you specifically it is an abrasion or it will tell you that it is a laceration with a foreign body and not that it is just an open wound or it is just a superficial injury. Detail for open wounds has been added at the fifth digit. So, you have examples in this slide of the detail that has been added at the fifth digit level.
Then laterality has been added at the sixth digit level, where you can actually show the laceration of the shoulder without a foreign body and specifically which shoulder or part of the body.
Extensions have been added to the external cause and injury chapters so that you can now identify the encounter as being the initial encounter for the treatment of that injury or whether it is a subsequent encounter for the treatment of that injury.
This has been suggested to us by a number of users of the classification. Currently, the injury code should only be assigned when the person is coming into the hospital for the first time for that injury. Afterwards, if they are seeking subsequent treatment, there are after care or follow-up codes that are to be used. However, there is not sufficient detail in those after care and follow-up codes. So, the users of the classification have said we want to be able to reuse the injury codes so that you are not losing the specificity about the injury, but they also wanted to be able to distinguish and initial encounter for the treatment of that injury versus subsequent follow-up.
So, by having extensions for the injury codes, we have been able to accommodate that.
The place of occurrence codes, as developed by WHO, includes a lot of information. At the fourth digit level, for instance, for home, you have a number of entities that are identified under "Home," apartment, boarding house, farmhouse, non-institutional place of residence. All of this goes under the fourth digit of home.
What we have done in ICD-10-CM is to add detail at the fifth character level to expand out the classification so that you can actually identify what you mean by "home." Is it a residential facility? Is it a farmhouse, et cetera? So, wherever you see an x, for instance, the Y92.0x, the x means that there is fifth digit specificity for home that has been added to the classification.
The same is true for Y92.1x under "Residential Institution." There is detail added for residential institution, for sports and athletic areas, et cetera.
A new feature of ICD-10 -- and, again, this is the WHO version -- was a fifth digit subclassification for activity, what activity was the person involved in when they were injured. The fifth digit subclassification says while engaged in sports activity. Many of the commenters that commented during the open period said, well, they really wanted to have a lot more information specifically about what sports activity that person may have been involved in.
So, in ICD-10-CM, we have expanded out at the fifth character level information about the activity that the person may have been involved in. So, again, wherever you see an x means that there has been added detail to the classification to capture this level of detail.
Based on the comments that we received during the open comment period, some of the commenters thought that there were major benefits to the enhancements that had been made; more information included in one code. It was easier to code. It reduced the need to look for several codes to capture the important information about the patient's encounter. It made data retrieval easier, as well as the analysis of that data, improved clinical detail and the full code titles would facilitate computer applications.
Some of the commenters also mentioned to us and, of course, we were very much aware of this, that this would require some training in order to move from ICD-9-CM to ICD-10-CM. So, yes, training would be required. However, the coding rules and conventions, basically remain the same and the structure of the classification, even though it is now alphanumeric, still is very similar to ICD-9 and ICD-9-CM.
So, while it was felt that retraining definitely would be necessary, that it wouldn't be a huge amount of retraining since the structure and conventions basically remained the same. It will require changes in data retrieval and analysis and a good example of that is in the injury section. Again, in ICD-9, ICD-9-CM, all of your fractures were within a certain specified range of codes, 800 to 829.
In ICD-10, ICD-10-CM, in order to look for your fractures, you actually have to run through a number of codes to capture all of the fractures, with the fracture information being at the third character level. Of course, I don't think that based on the experiences of other countries that have already implemented ICD-10 or a clinical modification, while it did require additional work, it doesn't appear that it was an insurmountable amount of work in order to accomplish the transition.
Where are we with ICD-10-CM currently? Well, we have reviewed the contractor's report that analyzed those 1,200 comments that we had received during the open comment period and we have analyzed those and included many of those into the changes that are now being made to the tabular list. We are pretty much getting through finalizing the tabular changes. We have a contractor who is actually updating the alphabetic index and revising the crosswalks.
The guidelines are simultaneously being revised in keeping with the things that have changed in ICD-10 and we have a contractor that is working on the development of the training materials. There will be an additional testing of ICD-10-CM. Under contract to the Health Care Financing Administration, their Clinical Data Abstraction Centers will be testing ICD-10-CM using 3,000 medical records.
Under contract to NCHS, we have some contractor, who will be testing ICD-10-CM in several hospitals across the country, both inpatient and outpatient records and we have other organizations that will also be testing ICD-10-CM; the American Hospital Association, the American Health Information Management Association and we have some other groups that have also expressed interest in doing the testing for ICD-10-CM.
They will be looking at ease of use of the classification and specifically testing some of the new features that we have added, also checking to see if additional index entries will be needed to make it easier to use and also looking to see if we need to add additional notes to the tabular list to make choice and selection of a code easier than it has been in ICD-9-CM.
With that, I will take any questions. I kind of sped through this because I know that you are kind of on a clock here.
DR. LUMPKIN: Thank you. That is appreciated.
Barbara.
DR. STARFIELD: Donna, thank you very much.
I have -- to give you time to catch, I will ask six questions.
DR. LUMPKIN: Six questions. I only recognized you for one, but go ahead.
DR. STARFIELD: They are all related.
First of all -- these are in no particular order -- the symptom coding, you know, there has been a big push and a lot of struggles about ICPC. To what extent does ICD-10-CM take care of any of those concerns about whether this could be used for reason for visit code, as well as a diagnostic code. That is No. 1.
No. 2, the old issue, which we have talked about before on this committee and that is the rule out and the certainty. Rule out dogs every effort at any time in using the system for risk assessment. It is a nightmare. Is there any way we are going to get any improvement on that?
The third one is double diagnoses in one code. This absolutely boggles my mind because there is no end to it. I mean, once you open the door to double codes -- and, you know, the atherosclerosis wit angina and that kind of thing -- I mean, everybody is going to want to double code everything. And not only that, but from a practical point of view, it is going to lead to upcoding.
You know, HCFA has been using or thinking about using the ICD for risk adjustment. I mean, it is just going to just make a nightmare in terms of upcoding if you allow the double diagnoses in one code.
The next one, why not extensions follow-up for everything. Why just for injuries?
The last -- there are only five actually. You must have doubled the codes. If ICD has got 2,000 or 2,100, you must have 4,000 with all the things you have added in CM.
MS. PICKETT: Well, ICD-9-CM, the diagnosis portion has about 11,000 codes and in ICD-10-CM, yes, we have probably doubled that but doubled it because that is what the users have indicated that they wanted because they wanted more specificity in the classification.
In areas where there has been no particular question or comment about we need more detail at this particular diagnosis level or this particular section. We have not expanded there, just because it was there to expand, but there is an ability to expand in the future. Only in those instances where we would know we would receive the most questions over the years, where we knew that there were specific questions about the .8, the other specified, where there were important clinical entities that were grouped into that particular code, where people felt we needed to have more information there, did we expand out.
So, it is not like we just went through and exploded out everything. We tried to do it based on the comments that have been received through the coordination and maintenance committee process, as well as the open comment period. So, we have tried -- I won't say we tried to keep it to a minimum, but we have tried to make this more user friendly and figuring more detail is probably better than having less detail, which is most of the complaints that we have heard about ICD-9-CM.
Now, going in the order that you asked the questions, I know that your favorite peeve has been the coding of possible, probable and suspected. That relates specifically to the guidelines and the difference between how you code with the inpatient guidelines versus the outpatient guidelines.
In the current version of the ICD-10-CM guidelines, the coding of possible, probable and suspected is the same for both inpatient and outpatient and you code what you know. If you don't know anything more than what you know, then you don't code a possible as if it was confirmed.
DR. STARFIELD: You know what that is going to do? Nothing because people do upcode -- anyway.
MS. PICKETT: I am not sure that -- see, there is a difference between coding according to official guidelines and then there is the issue of upcoding. Upcoding, I think you are quite correct that we can't correct what they do in terms of upcoding, but in making the guidelines the same on both sides so that you know consistently that when you are looking at a diagnosis, that that is what the physician diagnosed, not what the guidelines said that if that is the physicians suspected or wrote down as possible, that what you are going to be getting is the same that you get on the outpatient side is exactly what the physician knows at the time that that information is being written because I know that is what other users of the classification have said to us as well.
Possible, probable and suspected is a problem. And, again, the reason that that inpatient guideline existed was because when those guidelines were first created, it was to recognize the work effort of the facility in working up that inpatient. So that if you didn't know at the time that they left, that is where the work effort went. However, over time what has been said to us clearly was that is not the best way to handle the data. You need to just record what the physician actually knows. So, that is what we have done.
Barbara, help me with your other --
DR. STARFIELD: The reason for visit coding, the symptoms.
MS. PICKETT: The symptom chapter has been expanded, as has the Chapter 21, which has a number of the other reasons for encounter that are not specifically diagnosis or symptom related. We have worked with a number of groups to expand out that detail. In fact, I think some of that detail matches quite nicely with ICPC. Again, not at the exquisite level of detail of ICPC, but certainly a lot better than what we have in ICD-9-CM and what is in ICD-10 currently.
DR. STARFIELD: The other one was the biggest one of all and that is the double coding; you know, the two diagnoses in one, which is -- I mean, I can't -- you know, if some group said they wanted those two diagnoses, atherosclerosis with angina, you know, everybody is going to want that particular common combination.
MS. PICKETT: We didn't do it for everything and we did it in those areas where it was most frequently occurring, where the guidelines really -- the guidelines didn't help in trying to figure out which code should be sequenced first. So, by combining them, we felt that that would be giving the information in one shot, one code, with everything that you needed to know. We have actually started that in ICD-9-CM. So, this is just a carryover into ICD-10. We have already added some combination codes in ICD-9-CM and those requests have come through the coordination and maintenance committee and have been well received. So, some of those things are already in 9-CM.
DR. STARFIELD: But I think in your testing you better watch for upcoding because that has lots of implications for payment.
DR. LUMPKIN: Simon.
DR. COHN: Donna, first of all, thank you for a very good presentation. I will try to sort of stay out of the specifics of the discussion of the coding system because I think we could spend hours on specific issues related to it.
I am more concerned sort of generally and just have a couple of questions and thoughts. As you know, I am sure, the committee has a long history of being generally supportive of improved coding systems. I am sure this applies to this as well as anything else that comes to the committee. However, I think as you also know, there is a fair amount of consternation or not consternation, concern by the industry about the costs of implementation versus the benefits.
I am thinking, obviously, ahead to some point in the future and I have no idea when that is when this coding system may come before the committee as a potential replacement for ICD-9-CM for an industry-wide, you know, evolution, changeover, et cetera. As I look forward to that, obviously, issues that we are going to be thinking about having to do with cost and benefits and I am sort of curious, first of all, to -- I wonder if you might be able to make available to the committee -- I think there is a contractor report that you had identified early on that identified the benefits of ICD-10-CM over current practices. I wonder if that might be of some use to the committee just to become familiar with that and if there is anything else you have that might relate to the costs and benefits, I think that would also be useful.
Now, the other question I have from a very sort of specific issue has to do with your testing strategy. As I look at the type of testing you are doing, which is very, very coder centric and it appears to me that the only thing you are really testing in terms of ICD is can a coder code and can it be coded at HCFA, can it be coded in hospitals, can it be coded by a HNIA professional.
Clearly, ICD-10-CM is used throughout the industry for many purposes and it would appear to me to be a much more credible testing strategy if you began to include others in the health care industry, insurers, maybe managed care and others, as partners in whatever testing you do so that we could begin to hear about industry experiences with this as opposed to just hearing back in a year that these coders can code using ICD-10, which I presume they probably can. So, it is just once again a thought in terms of trying to identify any benefits as we move forward.
MS. PICKETT: Thank you for that comment.
We were also thinking about including others. I mean, we have invited other groups to participate in the testing. The groups that immediately came forward, again, have been the American Hospital Association and AHIMA. We have not heard from any other groups at this point in time that have indicated a willingness to test the classification. Even during the opening comment when we had the classification up on the web site, there were groups that did not provide comment.
So, if there are names, contacts within certain organizations, I would love to receive them from you so that we can follow up with them.
DR. LUMPKIN: Mike.
DR. FITZMAURICE: I was going to say virtually the same thing as Simon. He said it better, so I will just say it shorter. There is a question of the pressure on the U.S. to adopt this to be like the rest of the world and, yet, the need to assess the costs and the benefits in use for -- paying for the resources used in health care; the HIPAA process, the cost/benefit analysis. We have seen this in the testimony over the NDC and the J Codes, which is coming to a resolution at some point.
For business purposes, it would seem that the necessity of a coding classification system is to more precisely match the resources in health care delivery to the costs and eventual payment for those resources, using a diagnostic classification and then a procedure to list out the things that were done.
I agree with Simon that insurance companies should be very interested in themselves as test sites to see how payment would differ, depending upon whether they use ICD-9 or ICD-10. Like Simon, I, too, would hope the evaluation contract touches on the accuracy in being able to match the resource use and the costs of care, using this classification system.
That was shorter, right?
DR. LUMPKIN: Other questions?
[There was no response.]
I would like to thank you for coming and this is something, obviously, we will follow the process and we would like to hear from you again when you are further on in the testing.
MS. PICKETT: Once we have some of our reports back, we would be pleased to come back and provide the details of the reports.
DR. LUMPKIN: Great. Thank you.
Well, at this point we will proceed to the reports from the subcommittees and work groups. I would like to sort of take them not in the order that they are in the agenda, but rather to take those reports that have action items first, just mindful of our -- just above a quorum that we have and we want to take care of the business that requires actions.
MS. FYFFE: I have a question about your quorum.
DR. LUMPKIN: Yes.
MS. FYFFE: The roster in our packets lists 15 members of the -- 16?
MS. GREENBERG: You probably didn't count John because he is --
MS. FYFFE: Okay. 16 members. I thought we were supposed to have 18?
MS. GREENBERG: We have two who have not been replaced, Lisa Iezzoni and --
MS. FYFFE: My question is this --
MS. GREENBERG: We are two short in our formal membership. So, obviously, the quorum is based on actual number of members.
MS. FYFFE: Okay. Thank you.
DR. LUMPKIN: Let's go, Standards and Security -- well, we will start in the way they are and, Dan, do you have any action items?
DR. FRIEDMAN: No.
DR. LUMPKIN: Okay. And there is none from NHII. So, we will come back to them.
Standards and Security? I am sorry. Before we go to that, yesterday, as I understand it, we did not have a quorum to adopt the report, 50 year history. So, I would like to entertain a motion to adopt that report.
DR. COHN: So moved.
DR. LUMPKIN: It has been moved and seconded. As you know this report -- we have seen an earlier version of that. The full report has been approved by the Executive Subcommittee and now we are just going to the full committee adoption.
Is there a discussion or modifications, changes in the report?
[There was no response.]
Seeing none, all those in favor signify by saying "aye."
[There was a chorus of "ayes."]
Those opposed, say "nay."
[There was no response.]
I hear none. Any abstentions?
[There was no response.]
Then the report is adopted.
Simon.
Agenda Item: Standards and Security Subcommittee Action Items
DR. COHN: Okay. Well, we actually have two action items. One is the HIPAA draft report. We talked about this yesterday. This is on Tab 4. This is the fourth annual report to Congress on the implementation of the administrative simplification provisions of the Health Insurance Portability and Accountability Act.
What we are asking for is acceptance of this with revisions to be made by the Executive Committee and specifically those changes would be on page 4, the third paragraph, an expansion to the third paragraph that right now, obviously, applauds progress on privacy standards, but I think we also need to put in a sentence or two based on recommendations from the Privacy and Confidentiality Subcommittee that there also be a recognition that there really does need to be further action by Congress to cover wider issues related to the privacy of health care information.
I think we would draft this and probably circulate it to the full committee just to make sure that you are all in agreement with the wording, but that it would be finally approved by the Executive Committee.
The other change would be a redrafting of the -- on page 10 of the first full paragraph, which has to do with local codes to make, as Barbara Starfield mentioned yesterday, that paragraph a little more understandable and probably we will keep it at a relatively high level, not so much discussing local codes specifically but just a range of coding issues.
The plan here would be once again to have this submitted after Executive Committee approval. Once again, you all received copies of the, I think, proposed modifications to the privacy section and redrafting of this paragraph for review prior to going to the Executive Committee, but that would be the only changes.
DR. LUMPKIN: Simon has moved that we approve the report with the proviso that the two particular sections, privacy and coding issues would undergo revision. Those revisions would then be sent to the full committee for comment and then approved by the Executive Subcommittee to move the report forward between now and the next full committee meeting.
Is there a second to that motion?
[The motion was duly seconded.]
DR. LUMPKIN: It has been moved and seconded. Is there discussion?
[There was no response.]
Hearing none, all those in favor signify by saying "aye."
[There was a chorus of "ayes."]
Those opposed say "nay."
[There was no response.]
Abstentions?
[There was no response.]
That carries.
What we will do is we will -- when those revisions are ready, they will be e-mailed to all the committee members. You will be given a reasonable period of time, like about two hours -- I was just seeing if you are paying attention -- a reasonable period of time to comment and then those comments will be reviewed by the Executive Subcommittee and a final approval given.
DR. COHN: Okay.
Now, the next action item is a letter that you have in front of you labeled "Draft No. 4." I think it is being passed out. This has to do with NDC codes and we referenced this yesterday in a letter that needed to be reviewed by the Subcommittee on Standards and Security before it went to the full committee.
The background here, as I think many of you are aware, in the final rules on administrative simplification on financial administrative rules, there is a part of the world that states the NDC should be used instead of anything else for all uses around drugs and biologics. It came to the attention to the subcommittee and we held hearings recently on this piece of the final rule and there was concern, I think very legitimate concern by the industry that whereas NDC was quite appropriate for retail pharmacy transactions, it was probably not appropriate -- accommodate this and rather than reading all two pages of the reasons for it, I will just read the recommendations to HHS, just to make sure you are all aware of what these recommendations are. It is about three paragraphs.
This is recommendations on page 3. "It was clear that the industry strongly supports HIPAA and its administrative simplification provisions and is working hard to implement the requirements of the final rule. In undertaking these efforts, however, many problems with the requirement to use NDC to report drugs and biologics on the standard institutional and professional claims have become apparent.
"The problems described in testimony affect nearly all providers, health plans and health care clearinghouses and impede the ability of the health care industry to meet the HIPAA date. The NVHS believes the further evaluation is needed before a standard code set for drugs and biologics can be implemented in the standard transactions, other than for retail pharmacy.
"We, therefore, recommend that the requirement at Section 162.1002 (c) in the final rule of the standards for electronic transactions be modified by retracting the adoption of NDCs as the standard for drugs and biologics for use in standard transactions, other than for retail pharmacy. We recommend that NDC remain the standard for drugs and biologics in retail pharmacy transactions.
"The NCVHS recommends that HHS work with ANSI X12N to ensure that HCPCS codes, as well as NDC codes, can continue to be used in the standard institutional and professional claims transactions. The institutional and professional claims transactions should be able to accommodate NDC in cases where those codes are useful or needed."
In parentheses, "The ANSI X12N dental claim does not capture drugs. So, this issue does not affect that transaction standard."
"The NCVHS believes that no drug coding system in existence today fully meets the needs of the health care industry. HIPAA addresses drug coding primarily from a claims aspect; whereas, the future needs of the health care industry are for a drug coding system that can be used efficiently throughout the drug inventory, pharmacy, patient claim and billing arenas.
"The NCVHS recommends that HHS develop criteria that should be met by a drug coding system that could be useful throughout the health care industry and evaluate any future proposed drug coding systems against this criteria."
Then, "We appreciate the opportunity to offer these comments and recommendations." That is the body of the recommendations. I think from our view this is primarily a return to the status quo of using HCPCS, as well as NDC for drugs and biologics.
Questions or comments? Actually, does it need to be moved first?
DR. LUMPKIN: It has been moved that we send the aforementioned Draft No. 4. Is there a second?
[The motion was duly seconded.]
Moved and seconded. Comments?
DR. STARFIELD: That is a huge change, isn't it? I mean, we discussed it -- but could you just -- I know it is in the letter, but could you briefly summarize where the inadequacies are?
DR. COHN: Well, NDC, as I said, is very, very useful in retail pharmacy systems, where you have pills. You have bottles of pills and you are sort of tracking all of that. NDC does a great job of identifying the manufacturer, the size of the bottle, et cetera, et cetera. It is not so good when you are trying to get 750 milligrams of ceptryaxone(?) as an injection to a patient or 2 grams of gamma globulin as an injection because there is no way, for example, to specify that quantity of injection to a patient, which is really the types of information that is oftentimes submitted on a professional claim.
So, you are dealing with sort of incongruities here in terms of trying to figure out how to do this. I think the testifiers felt that the use of NDC was inadequate for those uses.
MS. FYFFE: Doesn't meet the functional specifications is basically it.
DR. STARFIELD: Doesn't have enough specificity? Is it mostly for institutional use?
DR. COHN: Well, NDC is once again really good for retail pharmacy and in some areas it is too specific. In other areas it isn't specific enough. In a sense, if you are in an institutional environment, provider or otherwise, you know, you have the vial, you have the medication and you want to inject it, you aren't necessarily concerned about what the drug maker is. Whereas, NDC is very concerned with what the drug maker is. So, it can tell you that.
On the other hand, you are concerned about the dosage, which NDC is typically not concerned about especially with multi-use vials.
Kathleen, do you have other comments?
MS. FYFFE: No. I mean, it is a mismatch.
DR. COHN: Yes, it is a mismatch.
DR. STARFIELD: Can I just comment? To what extent is this revision of it pursuant to or could be pursuant to concerns about adverse effects and safety? I mean, are we working toward a system, which would be better for that than the NDC is now?
DR. COHN: I think that is really our paragraph calling for the needs for an appropriate coding system. I think what you really are asking for, at least as far as I am concerned -- I am sorry -- what you are really asking for is a drug coding system that would be useful in order entry systems because that is really where the drug, the drug interactions, the allergies, all of this would come out.
NDC is not useful in that sort of environment because you don't always know exactly what bottle, what maker, et cetera, of an antibiotic or other drug you are going to be using. I think this is really when we -- for example, with the PMRI standard recommendations we were talking about the need for a better drug terminology that would meet those needs.
Now, J Codes are not optimal either but they are, I mean, I think, equally bad for different reasons. So, I think there is really a recognition that we had that there really needed to be a new terminology that sort of spanned somewhere between sort of the J Codes and NDC that was sort of useful for a variety of purposes, which I think is what you are describing.
DR. STARFIELD: You might add that to the letter, though, as further justification for reviewing. It is a big imperative now. If you have it, it is okay. I haven't read the letter.
DR. COHN: Is it the second paragraph? Yes, I think as close as we got to that was the comment that no drug coding system meets the needs, no recommendations.
DR. FITZMAURICE: I wonder if I could ask a clarifying question. The NDC codes don't specify the dose --
DR. LUMPKIN: Just a second so we can take care of that, maybe by inserting in that last paragraph, where the future needs the health care industry for a drug coding system that can be used efficiently throughout the drug inventory, pharmacy, patient care and billing arenas and also to assure patient safety.
PARTICIPANT: Good.
DR. LUMPKIN: Okay. I am sorry, Mike.
DR. FITZMAURICE: I applaud that addition.
I was going to ask a clarifying question. The NDC codes don't specify the drug dose. Do the J Codes specify the dose of the drug? I can understand -- unless there is a good reason to change, people would resist change. In this case, we will listen to the industry and the industry said do you have something better to offer us. And we are not sure the NDC is something better. But if the J Code specified the dose and the NDC codes don't, then the J Codes would be better on that score.
DR. COHN: Okay. Yes, they actually do. I mean, the J Code -- let me say publicly the J Codes are not my favorite set of codes and, yet, they do have -- for example, there is a code for 1 cc of gamma globulin IM injection and there is another one for 2 cc's and another one for 3 cc's and another one for 4 cc's, just as an example. It is not universal granularity.
So, I mean, it really does not meet our long term needs, but it is -- for the purposes which we are describing here, which is a claims transaction, I think most of this as we looked at this harder felt that it was a better choice than the NDC codes at this point.
DR. LUMPKIN: And there is a need to be able to identify drug manufacturers when there are bad lots and things like that. So, you know, I think our message is clear that what needs to be done is that we need to have a better coding system, recognizing that we shouldn't settle on one and allow there to be some flexibility so that we are not impeding the industry at this particular point.
When you consider that all the work that we have done with -- under HIPAA and the transaction codes and all that stuff, that this is one of the big issues, that really just says that we have done a fairly good job because this is really a -- I mean, to the people who have to implement this, this is a big issue, but in the scope of everything that has been done under HIPAA, it is relatively small and it is something that can be fixed.
Jim.
MR. SCANLON: Just very quickly, do we know of anyone who would oppose this recommendation? Does the committee have any information or heard anything of any -- just so the Secretary would be aware that -- or if there is or there isn't.
MS. GREENBERG: Well, it is my understanding from this letter that this would not -- you are not recommending that NDC codes be not be able to be used. I think there would be some, just from what I have heard, some opposition to that because I think some groups were recommending that NDC codes should not be allowed in the institutional or professional claim transaction, but that is not what the committee is recommending.
So, I can't say that nobody would object to this, but those are the objections that I have heard and that seems to address that.
DR. LUMPKIN: We have a motion and a second for the friendly amended Draft Resolution No. 4. Is there further discussion?
[There was no response.]
Hearing none, all those in favor say "aye."
[There was a chorus of "ayes."]
Those opposed say "nay."
[There was no response.]
Any abstentions?
[There was no response.]
Then we will send this letter on.
Any other action items from your committee?
DR. COHN: No.
DR. LUMPKIN: Okay. Privacy and Confidentiality, any action items?
Agenda Item: Privacy and Confidentiality Subcommittee Action Item
MR. ROTHSTEIN: Yes. The Subcommittee on Privacy and Confidentiality met this morning and we have one action item. We also have another recommendation that we can discuss at a later time.
The action item is a proposal that before the June meeting of the full committee, which is scheduled for June 27th and 28th, that there be a subcommittee hearing for informational purposes to discuss the implementation strategies for the HIPAA privacy regs. It was also suggested that we present to the full committee the issue of where that subcommittee hearing should be held; possibly outside of Washington at another location, such as one city mentioned was Chicago. It is a large city in Illinois, John.
DR. LUMPKIN: I have heard of it.
MR. ROTHSTEIN: That would be particularly convenient for the AMA, AHA, ABA and some of the other groups that are there.
DR. LUMPKIN: Okay.
Mike.
DR. FITZMAURICE: Would these be to develop strategies for implementing privacy or to examine implementation issues of people who are starting to try and have something to say?
MR. ROTHSTEIN: The latter. We would be soliciting testimony, comments, from the various --
DR. FITZMAURICE: Like early adopters.
MR. ROTHSTEIN: -- and to try to get a sense of what the problem areas are, what areas they have concerns about, what they are not sure how it works, what needs to be clarified, et cetera.
DR. LUMPKIN: Barbara.
DR. STARFIELD: You are operating under the assumption that there are going to be privacy rules, right? I mean, we heard yesterday the -- I mean, I guess there is a question about that, though, isn't there? We really won't know until April. Would you go ahead with the area anyway?
DR. COHN: Let me make a comment. I certainly don't think that we would schedule these before the effective date of the regulations. And certainly if there are no regulations, I think we would cancel the hearings. I don't think there is much point if there is not a regulation to be implemented.
MR. ROTHSTEIN: What we are planning to do, if the committee decides to go in that direction, would be to get the logistics in motion because you need to get all those things planned for and say we wanted to meet June 10th, and we can always cancel.
DR. LUMPKIN: I don't think we need a formal motion to approve that. I think that is consistent with our plan and, of course, Chicago is always -- works for me, although sometimes it is easier to make it to a hearing when it is out of town. But I think that that is a good idea.
Great. Anything else? Action items? You have a recommendation when we come back to the full committee report or subcommittee.
Populations? Action items?
DR. FRIEDMAN: No. I am sorry. No action items.
DR. LUMPKIN: Okay.
Paul, anything on functional status action item?
DR. NEWACHECK: Not an action item.
DR. LUMPKIN: Quality?
MS. COLTIN: No action.
DR. LUMPKIN: Okay. Then let's go to 21st Century report.
Agenda Item: 21st Century Report
DR. FRIEDMAN: After four discussion groups in D.C., after the CINSTAT workshop, after three local discussion groups and four regional public hearings, we are at a point we cannot -- and after the interim report, we can no longer avoid grappling with the final report. And we will no longer avoid -- we have not been avoiding it. So, it is now time to deal with the final report.
One of the things we have been doing with a great deal of help -- I wouldn't even say "help." I would say more collaboration, of course, with NCHS and particularly Rob Weinzimer(?), is reviewing what we have learned from the people who we have heard from in the regional public hearings and the discussion groups.
On the one hand, there were, not surprisingly, diverse opinions, but at the same time there was a set of common threads running through the discussion groups and the public hearings regarding the interim report, regarding health statistics as a field and regarding the contents of health statistics.
In terms of the interim report, we heard on the one hand, I think, support for the principles and the general vision expressed and on the other hand, we heard very consistently and I think the most consistent theme from all the meetings was that we need to specify to the greatest extent possible where we are going.
As Don Detmer said last June, we need a road map, a designated driver and a budget. And I think that very well expresses what we have to incorporate into the interim report, in the sense of specific, highly specific recommendations. In terms of health statistics as a field, one of the things that we have heard consistently, and Mike Rodreen(?) from California put it very well in the San Francisco hearing, was we need to talk in the report about health statistics and its need to demonstrate value, to return value for data producers, to create value for data producers and policy makers and to add value through use analysis and access.
We need to particularly in addition to that talk about providing incentives for data producers, for timely, accurate and appropriate data for the use of standards and then on the other hand disincentives for not doing that. Collaboration among multiple partners and then finally another emphasis that we heard was that we need to change the balance and particularly in the final report and in our recommendations, we need to change the balance away from data creation to data use and data access.
In terms of the contents of health statistics, one of the things that we heard consistently was I would say approval for our taking a broad view of the determinants of population health and taking a broad view of the definition of health, you know, obviously, away from illness, away from the absence of disease; the need for integrated data collection and analysis at the state and local level and the various subgroups, needs for data set integration and linkage in terms of standards and fasteners between data sets and in addition to that, need for longitudinal data and the longitudinal perspective, a health cycle perspective on the data that we collect.
In terms of the final report, the process that we are envisioning is that a small number of people who are in the collaborative will develop an iteratively detailed series of outlines of the final report and what essentially that means is myself, Ed Hunter and Gib Parrish from CDC has -- we are very lucky that he has joined the group and Rob Weinzimer will develop and iterative series of outlines. We will share those outlines as they get more and more detailed with the working group, as we did yesterday.
We will have a final report draft we hope -- our plan, our dream and our aspiration is to have a final report draft, first draft by July of 2001. That is not something that I am going to -- whatever -- bet my 403(b) Tiran(?) plan on because essentially it is going to be the three of us doing the writing. That would then be reviewed, further reviewed by the work group, as well as by the full committee, NCHS and presumably by the Data Council as well.
We would develop a second draft, hopefully, in August, August, early September. We would then circulate the second draft of the final report for external review, including expert reviewers and all of those who participated, lo, these many hundreds of people who have participated in discussion groups and hearings and we would also circulate that to key organizational stakeholders and their constituents.
Hopefully, that process will be completed by December and we would then try to incorporate their comments for a final report for review by the full committee and NCHS and the Data Council next February. As I said, that is the hope, the dream and the aspiration.
John, if you would like, I can spend a couple of minutes on the report outline or if you want me to just terminate here, I will be glad to do that.
DR. LUMPKIN: I think it might be useful if you do have a draft outline maybe to send it e-mail to the full committee.
DR. FRIEDMAN: Okay. Fine.
DR. LUMPKIN: Then it would be a good opportunity for them to see that and maybe give some comments because only the work group really has seen that. That is the functional status report.
DR. FRIEDMAN: Yes. We do have very much a first draft outline. We had good comments on it yesterday from the work group as well as from the Population Subcommittee and I will send it in and then that can be circulated further.
DR. LUMPKIN: Okay. Anything else from the work group?
DR. FRIEDMAN: No.
DR. LUMPKIN: I suspect there is an issue that you raised this morning that we will need to think about and certainly maybe you can report on that after we have had more discussions. We started out this process as a joint process with the Academy of Sciences and -- was it the Academy of Sciences?
DR. FRIEDMAN: No. NCHS and the Data Council.
DR. LUMPKIN: And the Data Council. And to what extent down the road as we get to a recommendation, we won't see that as our recommendation or recommendation of us and the Data Council. I understand there are going to be some discussions. But this is probably the first time, at least since I have been on the committee, where we have looked at a collaborative process with an entity within HHS. So, it will be useful to have some discussion at the next meeting.
DR. FRIEDMAN: Yes, it will and let me just -- you know, very quickly -- we have discussed that. We discussed that yesterday. I have discussed it with Ed Sondik and the report will be written in such a way -- essentially in a modular fashion so that will come a point where we could easily break off the report and have everything above the line be joint NCHS, the Data Council and the committee and everything below the line be the committee alone, but it could still be essentially a seamless report.
DR. LUMPKIN: Jim.
MR. SCANLON: Along that vein and including the next topic, the NHII vision and report we may actually want to have a substantive discussion at the next Data Council meeting or one soon after that, rather than have the report presented to the Data Council, when it is largely complete. I know John has given progress reports relating to both of them, but I think to the extent we could fill them on the substantive aspect, wherever it is, it would be helpful.
In addition, we are beginning to get some press attention to both reports and I would kind of like to have the leadership within HHS aware of those and not just have it, you know, plumped on their desk when -- after it has already been reported in the press.
So, I wonder, John and Dan, perhaps at the March or the April meeting, we could actually do more than just a progress report to the full Data Council, maybe go into the substantive aspects of wherever the report stands.
DR. LUMPKIN: Sure.
DR. FRIEDMAN: That would be a substantive report on the interim reports, not --
MR. SCANLON: Yes.
DR. LUMPKIN: Kind of a progress report because I think we have given --
MR. SCANLON: Mainly a status report because you have given --
DR. LUMPKIN: We have done a presentation, I think, on both reports, on where they were when we reviewed the interim reports, but I think maybe a progress report.
DR. FRIEDMAN: We did a presentation at CDC that I think would be applicable.
DR. LUMPKIN: Great.
NHII, as you know, we have had a series of joint hearings with the Work Group on the 21st Century. We have pretty much heard, as the process started out, we kind of made a mistake on the first hearing. It wasn't really a bad mistake. The mistake was that we asked people if they thought we were on the right track. And basically everybody said yes, yes, yes, you are on the right track and then we realized that after we were done with the hearing that that didn't help us much.
So, we began to be a little bit more focused in the next series of hearings to really ask the hard questions of what are the barriers, what should be done and essentially who should be the driver. It seemed to be fairly uniform in the responses that we heard that there is a very important role to be played by government in this process. It wasn't, you know, government keep your hands out, let everything develop as it might.
So, we are now in the phase where we will be developing our final report, we had toyed with the idea of developing a subsequent interim report and pretty much this morning we decided that that was not where we were going to be at.
We had some concern at our meeting this morning about the unifying theme and the theme that we are playing with, there are two strong themes that have come out. One is a shared responsibility, which is a concept of health being broader than just, much as Dan mentioned, that there are many other determinants of health, but it was in the context of the National Health Information Infrastructure that we need to bring that forward.
The second issue -- and we kind of came across almost a slogan that we are trying to work on -- and that is making the right decisions at the right time and that the goal of the system is to allow people, whoever is making that decision, which is a shared decision frequently between a caregiver and a patient, between a provider and the health system -- it may between a shared decision that is being made for a community, all the three dimensions, but that the information and knowledge that is necessary to make that decision so you can make the best possible decision ought to be available at the time when the decision needs to be made and that we are going to try to use that as sort of the unifying theme.
The work group will be developing a series of recommendations. We will be working on those over the next months. We will be sending out an e-mail with areas which we have split it off into areas of who will have responsibility, whether it be federal, HHS, state government, local government, providers and so forth.
If there are other members of the committee who would like to send in their two cents worth, without being a member of the work group, we would be happy to send you a copy of that e-mail to submit your recommendations. We will then start developing those recommendations into a matrix structure and, again, to flesh out the report towards the end of this calendar year.
That is just a brief status report. Any others on the committee want to toss anything or any questions?
MS. GREENBERG: [Comment off microphone.]
DR. LUMPKIN: That is correct. We will just do one final report.
Okay.
MS. GREENBERG: Just from -- this triggers my thinking that one -- we didn't actually label it an action item because we weren't exactly sure where it was going to be, but yesterday we did discuss the NCVHS update to the department, which is in Tab 5, and it was suggested that the privacy and populations -- well, I understand that the security, too, all three subcommittees discussed what additions they might want to make, recognizing we would still like to keep the document around five pages. I know that took place in each of the subcommittees.
I am also thinking in light of what Jim has said about there possibly being a briefing or a progress report to the Data Council -- and this was really intended to go -- be a short document to go to the new leadership and the Data Council, whether this shouldn't be an action item because it seems like it was ready kind of for that with the idea that the subcommittees in the next, say, two weeks would circulate their paragraphs and I think they each have a process in place for getting that going.
Then that could be circulated to the entire committee but finalized -- the document finalized by the Executive Subcommittee.
DR. COHN: So moved.
DR. LUMPKIN: Simon has moved that we approve the following process for approving the report to the Secretary activity summary and the -- let me just sort of say as an aside, the goal on this document was to be short enough that it will make it above the level of the Data Council so that as the issue keeps on coming up on what does this committee do with the new administration, they will understand what it is that we are doing and why it is important.
So, given that, Simon moved that we would adopt the following process, that the populations, the privacy and the --
MS. GREENBERG: [Comment off microphone.]
DR. LUMPKIN: And the Standards and Security Committee would develop their paragraphs. They would be submitted within the next week, that the revised full document would then be sent to the full committee for their comments. Those comments will be reviewed at the same time that the Executive Subcommittee reviews the annual HIPAA report to Congress and adopted by the Executive Subcommittee.
Is that agreeable? Two weeks because that still will be consistent with the time frame for the -- okay.
Is there a second for that motion?
[The motion was duly seconded.]
It has been moved and seconded. Is there discussion?
[There was no response.]
All those in favor signify by saying "aye."
[There was a chorus of "ayes."]
Those opposed say "nay."
[There was no response.]
Abstentions?
[There was no response.]
Then that motion carries.
We move to the report of the Standards and Security.
DR. COHN: Okay.
DR. LUMPKIN: Any additional items to report?
Agenda Item: Report of the Subcommittee on Standards and Security
DR. COHN: Well, yes, just very -- relatively briefly.
The letter that we just approved will -- and I think we have agreement from HHS about implementation. Everyone needs to know this will require a revised final rule for administrative and financial transactions, which as you all know is provided for in the regulations that the Secretary can make modifications to the final rules to promote and ensure implementation, et cetera.
So, you just need to be aware of this as part of this process -- and I think we have heard testimony as early as July of last year related to the desire by the health care industry to have the standards organizations and the DSMOs do a final sort of review of the implementation guides and the standards to make sure that all the data elements were really necessary.
I think you remember at the last full committee we actually heard some more testimony on that. The designated standards maintenance organizations have now implemented what is described as a fast track mechanism to elicit issues, concerns and otherwise with the current implementation guides and standards. That sort of period for comment closes at the end of this month and then over the next couple of months, the DSMO process, which as I said is essentially the same process, it has just been accelerated.
So, periods of time that used to be a month are now two weeks, et cetera, et cetera, but all the processes are in place to ensure appropriate input from the public and SDO sectors, et cetera. Hope to sort of have finished their work by late April to early May. Now the Subcommittee on Standards and Security will be holding a hearing -- first of all, will be holding a hearing in mid March on PMRI standards, which Mike Fitzmaurice and Jeff Blair are leading, which will be -- what is it, the 20th and 21st?
DR. FITZMAURICE: 19th and 20th.
DR. COHN: Thank you -- 19th and 20th of March, to talk about PMRI next steps, but we have also invited the DSMOs to meet with us at hearings at the beginning of May, which will be May 1st and 2nd, to further discuss the recommendations for anymore visions to the implementation guides and final standards. So, we have scheduled hearings for that date and also potentially if needed, also for May 31st and June 1st, with the plan that there will be recommendations to be brought back to the NCVHS at the June meeting related to any further modifications that need to occur as part of the revised final rule.
Obviously, the intent here, as I think we all heard from previous discussions, was for this to be valuable to the industry and to implementation. Any changes need to be communicated rapidly to the health care industry. So, any changes to software, changes to process, decisions about purchase or otherwise to software could be made in a relatively quick time frame.
DR. LUMPKIN: Any questions?
[There was no response.]
Simon, I guess I am not clear. Maybe it would be good for the members to also be a little bit clearer. Your hearing schedule for the --
DR. COHN: We have an aggressive hearing schedule coming up. We are dealing with two separate issues; one, which we already agreed to, which was an issue related to patient medical record information, recommendations and next steps, which will be March 19th and 20th in Washington, D.C. the primary focus of that discussion will be eliciting input from the industry on PMRI next steps.
Mike, do you want to make any comments about that?
DR. FITZMAURICE: Essentially, we have laid out a process where we have a set of criteria for selecting patient medical record information standards, have a trial list of such standards. We have a set of questions for standard developing organizations and we have a set of open questions for testifiers, soliciting their input to the process whereby NCVHS makes recommendations to the Secretary about the advisability of patient medical record information standards.
DR. COHN: Now, in addition to that, we also have hearings scheduled for May 1st and 2nd and, if needed, also May 31st and June 1st to take recommendations from the designated standards maintenance organizations on any needed changes or recommendations related to changes to the standards, the administrative and financial transaction standards and implementation guides that will be brought forward to the full committee in late June.
DR. LUMPKIN: Any scheduled into the summer, just so we can take us to September?
DR. COHN: I actually don't have anything scheduled beyond that at this time for the subcommittee.
DR. LUMPKIN: Privacy and Confidentiality?
Agenda Item: Report from the Privacy and Confidentiality Subcommittee
MR. ROTHSTEIN: Yes. The other item that we discussed or one of the other items that comes as a recommendation is that at the June meeting of the full committee that we ask for a briefing from Dr. Greg Koski, who is the new director of the Office of Human Research here at HHS, to discuss the issue of privacy and confidentiality issues in research.
So, that comes as a recommendation to the chair for consideration on the June agenda.
DR. LUMPKIN: I am sure the chair will be easy.
MR. ROTHSTEIN: The chair should remember that we just moved our meeting to Chicago earlier.
DR. LUMPKIN: Yes. That shouldn't be a problem.
Any scheduled hearings? Well, yes, the hearing. The finality of the privacy rule. Okay. Great.
Populations.
Agenda Item: Report from the Populations Subcommittee
DR. FRIEDMAN: In my role yesterday as facilitator, we held a meeting and let me just quickly summarize some of the things we discussed and then I will turn it over to Paul and Vickie.
We essentially discussed three things; the future role and activities of the subcommittee, the functional status report that Paul will spend a couple minutes on, and comments on OMB's December 2000 guidance on the implementation of federal standards for race and ethnicity data collection, aka, OMB 15.
In terms of the role, you know, one of the things that we felt that we really need to do is very self-consciously acknowledge that now the subcommittee is in a transition period, which, hopefully, will be out of the transition period after July, August, September, after we have some new members.
During that transition period, we talked about the need to review the charge for the subcommittee to define populations within the charge and the subcommittee members agreed that that would be done through a conference call in the next couple of months.
We also talked about criteria for new projects and those subcommittee members who had been on the subcommittee for awhile reflected that the choice of some of the topics has not exactly been idiosyncratic, but has reflected more some of the individual interests of the members than any larger strategic plan.
One of the things we talked about was that in choosing longer term projects, we need to have a very clear client before we go forward and also in choosing new projects, that it would be helpful if we could explicitly fit them into a larger model of the determinants of population health.
The subcommittee agreed that there would be more of an emphasis, I think, on short term activities, perhaps with one hearing or a panel and production of brief letters. Future activities -- and these were not discussed in any detail -- one of the things that actually -- that Jim mentioned, Jim Scanlon mentioned, was the possibility of having directors of some of the statistical agencies provide periodic updates to the subcommittee.
You know, personally in thinking about that, Jim, I think that would make sense to do for the full committee actually because right now we really hear from ASPE and we hear from NCHS, but that is a somewhat restricted view. That is my own personal view.
The other topics that have been mentioned over the past several months as possibilities included summary health measures and their application at state and local and subgroup levels, geocoding and economic position, fair information practices for health statistics. That would clearly be something that would be done with the Privacy Committee.
Further work on data for eliminating and defining disparities, particularly around not only racial and ethnic but also economic, gay, bisexual, lesbian and transgender. There was some discussion yesterday on data on language use, surveillance standards across a full range of public health data sets and then finally the implementation of the revised federal standards for race and ethnicity.
So, I think the immediate activities, we will need to be reviewing -- the subcommittee would be reviewing the charge and thinking about criteria for new projects.
With that, Paul.
DR. NEWACHECK: Let me just give you a brief update on our functional status report. We on the subcommittee have completed a series of hearings and working sessions on the functional status project. At this point we are beginning to draft a report, which will contain our findings and recommendations on use of functional status and administrative records and computerized patient medical records.
Our goal is to have a final draft version of that report ready for review by the full committee by the middle of May and then we are proposing to include it as an action item on the June 27th, 28th full committee meeting. So, that will give time for comments and refinements before the action item.
We also, though, do anticipate having at least two draft versions circulated by e-mail in this interim period between now and May 15th or so. So, if there are any committee members, who would like to participate in reviewing those drafts or participating in at least one conference call that we are going to be scheduling, you are all welcome to do that and please talk to Susan Kinon(?) if you would like to join that process.
The report itself is going to describe the importance of functional status in its applications in medical records. It will describe our assessment of various approaches to conceptualizing and measuring functional status. It will also describe some of the potential difficulties in incorporating functional status in administrative data and in patient medical records. It will also contain a series of recommendations and I can just give you sort of a general sense about what those recommendations are at this point.
The first of those is that we as a committee strongly support the notion of including functional status in administrative records and in computerized patient medical records. We think it is very important. There is a broad consensus on that topic.
We also feel there is broad agreement within the committee on the notion that the ICIDH-2 is the best measure or classification tool for capturing functional status at this point in time, but we do recognize that there are some logistic issues concerning the ICIDH-2. It has not been well tested at this point. So, more work is needed before it can really be ready for prime time or for the purposes that we have in mind. But we feel very strongly that it is the single best candidate tool for classifying functional status and that will be one of our recommendations.
So, that is basically what the report will capture. We do have some additional issues that we would like to refer to some of the other subcommittees. There are ongoing privacy issues that we would like to refer to the Subcommittee on Privacy and Confidentiality.
So, that is basically where we stand at this point.
DR. FRIEDMAN: Simon, do you have a question?
DR. COHN: Paul, thank you for the lateral.
Let me make the following comment, though, because I mean, first of all, what I understand of ICIDH or ICFDH, which is, I think, what I am going to start calling it from now on, you know, it seems like a very good -- it seems potentially a very good coding system for functional status and especially has applicability for questionnaires and other things that one could imagine functional status being used in.
Now, the area that I have a little more of a question in my mind has to do with the use of functional status as a data element in I think we describe it the administrative and financial transactions. Now, it may be appropriate to use it there, but I am just having a hard time trying to figure out where it should be used.
DR. NEWACHECK: We are talking about claims and encounter forms.
DR. COHN: I know, but I mean, I am just trying to get -- as a routine element is what you are describing?
DR. NEWACHECK: Yes.
DR. COHN: Well, I guess the question I would have and this is not something you should lateral off to the Standards and Security Subcommittee, but have you had a discussion with the owners of those standards to being a discussion of where they think -- I mean, what they think the role of functional status is in all of those? I mean, have you heard testimony from X12 or others about that?
I mean, before you are all done, you might ask them to come in and meet with you to discuss that since they are at the end of the day the owners of the standards.
DR. NEWACHECK: We were hoping that you guys would do that, too.
DR. COHN: Well, we are happy to actually have a joint meeting with you if that will be useful, but that seems to me to be an important part of the discussion because as I said if what you are doing is saying that HHS use that in questionnaires, that is one set of recommendations, but if what you are trying to do is to have a discussion and get the industry to implement involuntary standards development processes functional status measures, that is an entirely different discussion that you ought to be having.
DR. NEWACHECK: It needs to be done now.
DR. COHN: Okay. So, it is just a -- I think it is something -- and maybe it is something that we all do as a committee is bring them in and have a discussion with them around that issue because it is one thing to say "yes," if you are going to do functional status, use this coding system. It is a whole other thing to say, gee, should you put functional status in here and if so, where?
DR. NEWACHECK: Right.
DR. STARFIELD: Just a couple of things to point out. It is an element in the core data elements.
Second of all, let me just -- you know, some providers do deal with this routinely in a clinical setting, right? And some people think physicians should deal with it routinely, too. So, it is not really out of the realm of even consideration in terms of clinical transactions and, therefore, administrative data.
DR. COHN: Can I respond to that?
Barbara, yes, I agree with you and as I remember the core data elements are if you are going to use that element, use it this way. I think functional status is an important element, but I am grappling with for it to be actually implemented into something, people need to sit down and figure out under what circumstances are you putting functional status in? Are you just using it for -- under certain circumstances for certain classes? In other words, is it a situational data element? Is it required data element? These are whole things way beyond the data -- the core data element issue.
DR. NEWACHECK: Those are complicated issues, but I do think your point of at least trying to make some inroads with talking with other groups and that before we come up with a final report would make a lot of sense.
DR. COHN: Yes, and I think X12 in particular would be a very -- I think to hear their views -- I mean, to ask them their views to get them thinking about it and then to hear what they are having to say and their thoughts about this one would do a lot to, I think, help inform all of this.
DR. LUMPKIN: It may also be useful to invite somebody from the NEDS(?) project to that hearing because I think functional status is going to be important in any electronic registry.
MS. GREENBERG: [Comment off microphone.]
DR. LUMPKIN: No, it is electronic disease surveillance.
DR. COHN: Maybe it is for the July -- for the June NCVHS meeting, since we are already going to have somebody from the NEDS group.
DR. LUMPKIN: Right. But, you know, to the extent that CDC is also involved in reporting and monitoring of chronic illness --
MS. GREENBERG: [Comment off microphone.]
DR. FRIEDMAN: We were hoping to have our final report ready by the June meeting. So, maybe we will think about some interim strategies if that would work. If not then maybe we will delay that report and use the June meeting as an opportunity to hear from some other groups.
DR. LUMPKIN: Anything else on functional status?
I think that we can think of a strategy and it may be that a recommendation on insertion into the transaction forms may be a follow-on recommendation. So, I would not like -- if this is an issue that seems not to be resolved by next June, we can pass the report and kind of beg this issue and then follow up with a follow-up recommendation.
MS. GREENBERG: That was really kind of the way the discussion -- I think that is consistent really with the discussion yesterday, that this be something that should be considered and explored as opposed to that it should be done because there were, obviously, recommendations related to testing and other issues, at least around the ICIDH. I think particularly as you may know, Dr. Iezzoni has agreed to remain involved, even though she is no longer on the committee, at least as a -- her expertise and she did chair all of the hearings. So, it would be desirable if the report could be at least Phase I could probably be brought to closure by June as Paul suggested, but, obviously, that can be explored.
DR. LUMPKIN: Anything else on functional status? Anything else on the subcommittee?
DR. FRIEDMAN: Yes. Vickie.
DR. LUMPKIN: On B15.
DR. MAYS: One of the issues on the committee yesterday was to talk about whether or not we thought we would be able to respond to the document, which is known as the Provisional Guidance on the Implementation of the 1990 Standards for Federal Data on Race and Ethnicity because the deadline is March 19th.
So, part of the work yesterday was to figure out whether or not there were some things that we could agree upon and get this out quite quickly. Just for those of you who are not on the Internet, but in the room, but just to show you, this is actually the guidelines themselves. So, we are talking about approximately about 200 pages of material. Those of you who have been keeping up with this area, you know that there have been lots of discussions that have taken place in the field.
For example, these were all papers from a couple of the meetings that have taken place on this issue. So there is quite a bit of discussion that probably if we are going to comment needs to be reflected in the document.
So, as we went through it yesterday, I think what we thought that we could do in the limited time that we have instead is to talk about some of the issues, to send a letter of intent and in the letter of intent let them know that we are going to discuss this further and that these are some of the issues that we are concerned about and leave it at that.
So that we can at least get into the record by the 19th. Then after the 19th, part of what we will do is continue to work on this and then determine, for example, whether it would be useful for us to have even just some informational hearings, whether it is useful for us to, you know, have our colleagues at some of the various agencies come in and give us updates on the guidance that they are following in implementing this.
Then I think from there we might be in a better position to actually send a letter that has some definitive comments and recommendations.
DR. LUMPKIN: So, as I understand, you are making a motion that a placeholder letter be sent from the committee to OMB before the cutoff date, which would be the 19th of March?
DR. MAYS: Yes, I am making that motion.
DR. LUMPKIN: It has been moved and seconded. I think we need to talk a little bit about process because we have a couple of things that are working its way to Executive Committee for approval that the committee has seen in one format, which this would not -- I don't think would fit within that time frame because I think we are looking at maybe having an Executive Subcommittee in about a month.
So, this would be, I guess, to authorize me to send such a letter, this proposal.
DR. COHN: What would that letter say? I mean, if, indeed, we have no idea what the contents of the letter are, maybe the process needs to be a conference call that we approve the contents of the letter, unless, Vickie, do you know what the contents of the letter is?
DR. MAYS: I think there were a variety of suggestions and I don't know exactly which of these we want to use. One was the possibility since it is a letter of intent and not necessarily we are making recommendations, that it might even come from the committee, given that we do need a bit of time to be able to -- I am sorry -- the subcommittee -- thanks -- the subcommittee, given that we need some time to be able to pull this together. The other would be to see whether or not we can do this quite quickly, which then puts us into, you know, a time frame where what we try and do is send it out to -- let me make sure I have it straight -- send it out to the full committee for comments and then I guess the full committee comments -- maybe you can help us with that.
MS. GREENBERG: There were different suggestions about the type of letter, but I think from what you have said the conclusion was that at most it would be a letter of intent, that it would not actually include substantive comments on the provisional guidance or recommendations for changes.
Also, there was discussion that even when OMB is through issuing its provisional guidance, that there can certainly be work done in the department as to the extent that the rules allow flexibility, et cetera, to make recommendations to the Data Council about more or less consistency among programs in the department. So, it doesn't end -- the treatment of this issue doesn't end with comments to OMB.
But the letter of intent -- so, I guess the question is whether this letter of intent, at least alerting the OMB to certain concerns or issues that the subcommittee or full committee feels need to be explored, whether that should come from the subcommittee or the full committee. If it comes from the full committee, given that we feel that the letter should get there by the 19th, the date of the 19th, how you want to do that.
One possibility is -- I mean, if it could get drafted in the next two weeks, I guess, given that it is going to be a pretty short letter, I guess, the letter of intent, then it could be circulated. It is not clear to me whether this -- I don't think this constitutes any kind of formal recommendation. So, it is not clear to me that this requires a vote on the letter because it is basically a letter of intent to provide further comment, recommendations, et cetera, that would go through the whole approval process in the committee.
I don't know that we have that much precedent for this. The real issue is this March 19th deadline for commenting on an extremely thick set of documents, but in an area where the committee has been active for many, many years and probably wants to continue to be.
DR. LUMPKIN: Did we not make comments on the first round?
MS. GREENBERG: Yes. Comments were made on the actual guidelines that this is now implementing on the actual classification or changes to the OMB 15, as it were. It is actually changes to the OMB 15. Comments were made on that. Now we have guidance about how to implement the new OMB 15 and this is what we are talking about commenting on. It gets a little complicated, but the actual categories were approved. They were -- you know, the classification, the minimum classification of race and ethnicity was modified. It was used in the census, but there are a lot of different ways that this can be implemented. This is what this guidance -- and particularly the tabulation and use of the data.
DR. LUMPKIN: Yes. I just want to ask -- and I asked about whether or not we commented because I wonder if perhaps we could just use a cover letter and say, you know, we sent in these comments about the rules. We still have some concerns. We intend to have further discussion in the future.
MS. GREENBERG: This is really kind of a different issue, though, because this is how now you implement the guidance that was adopted.
MR. SCANLON: -- to OMB at all. Maybe that the issues really are at HHS and it is not necessary to have a letter to OMB by the 19th.
DR. MAYS: I think it is important to at least be on the record, the official record, and, again, in the meeting, part of what we talked about is that there is very simple things that we can say and we kind of moved away from that and just said we would send a letter of intent. I mean, I think there are some things that are like really clear agreement in terms of like the issue of tabulation and, you know, wanting to make sure the data is available for people to use and the ways in which they can really answer and respond to their mission. I think that the issue of bridging is another one that is very important, that, again, we are all probably come out on, you know, pretty much in the -- I think in some agreement about that.
There are lots of other issues, though, that exist in that document that I am not as sure that we would --
DR. LUMPKIN: Okay. We need to come to some conclusion before we lose our quorum.
Dan, do you have a suggestion for a process?
DR. FRIEDMAN: I do not have a suggestion for a process.
DR. COHN: I have a suggestion for a process, a general process when we are dealing with things that wind up needing to go out of the committee is that we draft a letter. We have a conference call to approve it and then it gets approved and sent out. If the only thing that this letter says is, gee, we are going to plan on commenting at some time in the future, that isn't necessary. But you are talking about substantive issues. So, I think it needs to go through that process.
DR. LUMPKIN: Okay. So, what we will do is that we will circulate the draft letter to the full committee, send the comments in and the Executive Committee will then vote on the --
PARTICIPANT: I think it has to be the full committee.
DR. LUMPKIN: So, your proposal would be the full committee conference call?
MR. SCANLON: I think probably take a draft letter from the principal author, circulate it electronically to the full committee and then wrap it up in the Executive Subcommittee.
DR. COHN: I amend my motion.
DR. LUMPKIN: It has been moved to circulate it to the full committee, vote by the Executive Subcommittee. All those in favor say "aye."
[There was a chorus of "ayes."]
All those opposed say "no."
[There was no response.]
Abstentions?
[There was no response.]
It passes.
PARTICIPANT: I do think that as Jim has said and as Marjorie said, the real money here is less in OMB 15 and more in CDC and HHS and around issues of standards for data collection.
DR. LUMPKIN: Are there plans to conduct hearings to that end? I mean, because, obviously, once we send the letter and put the placeholder in, then we need a work plan to begin to address that. I am not saying that there needs to be before the next committee meeting. Perhaps at our June meeting or at the June meeting, the subcommittee, the work plan can be put together to begin to have a fuller response.
Do we have any other items to discuss?
MS. GREENBERG: We will reschedule Dr. Koo for hopefully the June meeting.
DR. LUMPKIN: Yes.
MS. GREENBERG: We have been asked to have a presentation from Mr. Koski and any other recommendations for presentations or topics for the June meeting should be e-mailed to Jim and me.
[Multiple discussions.]
Anything else that people know already?
DR. LUMPKIN: Obviously, functional status will be on the agenda but -- and we will need to just spend some time with the Work Group on NHII.
DR. FRIEDMAN: If there were time and I don't know whether this should be dealt with in terms of the subcommittee or the full committee, it may not be a bad idea to get representatives from CDC, from HRSA, et cetera, to spend -- have a brief panel on OMB 15 implementation.
DR. LUMPKIN: Okay. Let's see how that --
DR. FRIEDMAN: Excuse me. Thank you, Barbara. I mean data collection.
DR. LUMPKIN: Marjorie looks troubled.
We will play with the agenda and it will be there or in the following meeting.
Okay. I think we have exhausted both our agenda and our quorum. So, at this point, those of us who live in northern climes and realize that a couple of inches of snow doesn't mean much, but in Washington, it is a big deal. So, we will adjourn at this point.
[[Whereupon, at 12:15 p.m., the meeting was concluded.]