[This Transcript is Unedited]
P R O C E E D I N G S (2:36 p.m.)
DR. COHN: Will the members of the committee introduce themselves?
DR. FRAWLEY: Kathleen Frawley. I work for St. Marys Hospital in Passaic, New Jersey, and I am a member of the subcommittee.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation and I am a member of the subcommittee.
DR. FYFFE: Kathleen Fyffe. I work for the Health Insurance Association of America. I am a member of the subcommittee.
DR. HUMPHREYS: Betsy Humphreys from the National Library of Medicine. I am a staff person to the working group on computer-based patient records.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and Quality, liaison to the National Committee and staff to the Subcommittee on Standards and Security.
DR. EMERSON: Mary Emerson, Health Care Financing Administration.
DR. GUILFOY: Helene Guilfoy, Phoenix Health Systems.
DR. SCHULTEN: Kathryn Schulten, New Era Networks.
DR. BARRETT: Lee Barrett, WITI.
DR. BLAIR: Jeff Blair, Medical Records Institute, member of the Subcommittee on Standards and Security.
DR. KOLODNER: Rob Kolodner from the Department of Veterans Affairs, staff to the Subcommittee on Patient Medical Records.
DR. MC DONALD: Clem McDonald, Indiana University and a member of the subcommittee.
DR. COHN: Jackie, do we need to have people in the audience identify themselves? Is that necessary for this? No, okay. In the interests of time, let's not go through that.
We are off the Internet, however we are being recorded, and there will be a transcript for this, just for everyone's information. Remember to speak into the microphone.
Before we get back into the questions and discussions from this, let me just observe that obviously we have got a lot of things on the agenda for the subcommittee. Following the HIPAA implementation is clearly -- it is on the top of the list, along with new standards and changes to standards. But obviously we have a whole bunch of other things that we are all aware of, including the PMRI standard, next steps, code set issues which we have begun to talk about, and of course following along with the NPRMs as they begin to come out.
Now, I would also comment that the next set of hearings for the subcommittee will be February 1 and 2. I would suspect that as we begin to talk about what we're going to talk about now, we will also discover that there are probably some follow-on items for the February hearings.
We obviously are running a couple of minutes late, what else is new? But I think we have intended for there to be some time to continue with the discussion and questions around what we just heard. We'll ask Kepa to talk about digital signatures and next steps. Dr. Clem McDonald will then be talking about a claims attachment update. Jeff Blair will have some time to talk about next steps for PMRI standards, and then we'll talk some about the January hearings as well as other next steps that need to be occurring.
With that, I want to give the floor back to our panelists and open it up for questions again. We all have a number of questions. Kathleen, are you raising your hand?
DR. FRAWLEY: Actually, it wasn't a question, it was a comment to a question that Mark raised on the release of information. I think one of the problems that we are seeing is the fact that many of the requests that health care providers are receiving are from managed care plans and third party payors, who are requesting complete copies of the medical record in order to reimburse a provider for health services rendered.
I certainly have been in the position in the last six months where I have attempted to provide only a copy of a discharge summary or only a copy of an operative report or perhaps a mammography report of a CAT scan, depending on what the scenario was for that encounter. I have had the requests come back, indicating that until a complete copy of the record was provided, that the claim would not be reimbursed.
So to some degree, providers are almost held hostage. Unless the privacy regulations clearly lay out and address this particular issue, it doesn't make any difference whether we have claims attachments or other types of things. We have to have some strong criteria for authorizations for disclosure of health information.
Secondarily, what is the minimum amount of information necessary to fulfill that request? There was language in the NPRM specifically that addressed that. I don't know obviously what the final form of the regulations will take. I do know from conversations with HHS staff on this particular issue, they had asked me to provide them data on specifically the types of requests that my organization was receiving from third parties, breaking it out by type of request and what types of information they were looking for. We were able to provide that, because our information is computerized, but not every hospital is.
The question that comes up is, how can you limit access to information when you are dealing with payment of a claim. So I just wanted to raise that as a comment.
I have a bunch of other questions that I'll raise, but I'll defer to -- I know Kepa has several.
DR. COHN: Let me start with a question. It is off this point, but I think it has a place in a claims attachment discussion as well as a privacy discussion for tomorrow.
I was holding the question I think primarily for Lee, but also maybe for Katherine. I find myself feeling that there was some sort of a disconnect in what I was hearing between the three of you. Lee, I hear you -- and I am actually very impressed with the work that WITI and the SNIP are doing in terms of developing work teams and plans and a project that seems to me is almost based on the assumption that providers have this data in their systems, and this is primarily a question of translation and reformatting, and let's get this information in and out in a timely basis.
I was hearing very much from Helene that providers don't have that data to begin with, so any implementation schedule you promote, a test or otherwise, might be of value to clearinghouses, but probably won't be something that most providers could be able to do. I didn't hear anything in your plans or comments that seemed to address that. Can you comment, please?
DR. BARRETT: Yes. I'm going to have Don Bechtel, who is the chair of the group, because they have been working, Simon, specifically on the criteria. So I beg the indulgence to have Don answer the question.
DR. COHN: I am also willing to have Don tell us that what we heard was wrong, also. That is an okay response, if indeed -- maybe there is some error in the evaluation. But go ahead.
DR. BECHTEL: No, I won't go there. What I would say is that WITI is also working with vendors. Vendors are very much a part of the process. So where we are finding what we would call SNIP data gaps, where there is no data to meet the need, these issues need to be brought forward so that we have a way of closing the gap.
So we are looking for vendors to get as much involved, and I represent a vendor as much as a clearinghouse. We are participating in this process, trying to understand what our obligations are. I'm sure that we are providing the necessary facilities within the applications to capture and store the data.
But this also implies that you have to deliver software updates, you have to get the software so that the customer is using it. So there is a lot of provider issues, as much as there are vendors issues, in terms of capturing it and getting it into the systems and doing it consistently.
So part of the issue is, what are the right ways to capture the data, where we have ambiguities, we're not sure, where we have inconsistencies, we're not sure. So we need to set some guidance. We need to say this is what the industry should be doing, and try to close those kinds of issues.
So that is very much what WITI is working towards, in my opinion.
DR. BARRETT: Let me just take one second to say that Don represents for example SMS. We have HBOC and a number of the key hospital information systems vendors involved in WITI.
Certainly, I think the issues that are brought up are valid. What I can tell you, Simon, is that we are trying to the best of our ability to work with, and making sure that we have got all the right constituencies represented on WITI, to assure that -- we are not taking a time line and saying, one size fits all, because it doesn't.
So what we are trying to do is to take into consideration, as I think Don was saying, what are the various components that we have got, and where are the various stakeholders in this process. Certainly from the provider side of this equation, you're absolutely right, they don't have all the data. We are not assuming that they do.
So we are trying to take all of that into consideration when I was going through the rationale that we have come up with for the sequencing. That is all part of the matrix we have come up with to determine that sequencing of the transactions.
So we have tried to take all that into consideration. That is what I can tell you.
DR. COHN: Kepa?
DR. ZUBELDIA: I have a question, maybe for Helene, maybe for Lee and Don, I am not sure who is going to answer this. But it is more a philosophical question.
As far as I know, the claims are being paid today, most of them, except for one of my children that keeps being knocked off. The same guy keeps being knocked off every month by the health plan. Everybody else is getting paid. They are being paid today based on HCFA 1500 or equivalent or UB-8 or equivalent, with the requirements that we have today.
I have a concern with what is happening. The implementation guides are consensus developed documents. The concern that I have is that in those guides, there seems to be a requirement for additional information that is not being used today. It is now required.
I am wondering if there are some flaws in the implementation guides. I am wondering if some of those requirements should be released, and not require that information. I know at this point to change the guides is very difficult, but I think that to change industry practices may be more difficult and certainly more expensive than to release some of the requirements in the guide.
For instance, the two items that Kathleen brought up, provider taxonomy and payor responsibility sequence. The provider taxonomy normally doesn't change from claim to claim. Most of the time, the provider specialty stays the same. The payors know that provider specialty. Why require it to be sent in every claim when it is a constant and the payor already knows?
The payor responsibility is something that the provider typically doesn't know. The provider knows that this patient has two or three insurance companies and doesn't know and doesn't care who pays first. The payors already know that information, they have it in their files. But why require that to go in every claim?
So it seems like we are mandating through the implementation guide mechanism to change the business rules. Maybe it should be the other way around. Maybe the implementation guides should reflect existing business rules today. What is your reaction to that?
DR. BARRETT: I'll take an initial shot. It is a good point. I think some of it goes to what, Kathleen, you were saying, too.
What I can tell you is that I have been on the payor side of the equation for about 22 years. A lot of the practices that have been in use -- and this goes down to the request for additional information, which was your point, that in many cases, the payors due to practices will request information because that is just the way they have always done it.
What we have tried to do, when I was working with a number of the major payors, was to try to get the payors to change their practices to get to the point where they would allow certain conditions to go without requesting additional information, and then go back and audit later. If based upon the audit they were able to determine that this is working fine and we're not seeing any abuses here, then let it continue and don't revert back to request the information.
Kepa, part of this has to do with the fact -- what you are saying is, rather than changing the practices, the business practices, let's try to change it through the implementation guides or some other mechanism. That is an approach, and it is certainly an approach that we could take. We could certainly modify the implementation guides in future releases to do that. There is nothing that precludes us from doing that, and to potentially start to modify some of the business practices out there, through the methodologies and the processes that we use.
But I still think that at the same time, we need to work on the business practices, and to get to the point where -- I don't believe in all cases that we need to ask for additional attachment information and all of that information. There is no reason we can't ask for some subset of that information or what is required to be able to pay the claim. That is I think the point that you were making, Kathleen.
So the issue is, certainly all I can tell you is that a number of the payors -- we are working on pieces of that. There is a lot more work that has to be done there. Because it is practices that have been used for years and years, they have not relaxed some of that, but they are getting to the point where they are more open to being able to change and being able to audit later.
That is going to have to happen, and I think we need to continue to focus on that, and potentially supplement it with potential changes that we can make to implementation guides or other components here. There is nothing that precludes one or the other, but I think we need to continue to work on both sides of the equation, not just one versus the other.
DR. COHN: Other comments from the panel?
DR. GUILFOY: Yes, I have one. One of the numbers that I have heard and often used is, it is wonderful that we have health care standards, it is unfortunate that we have so many of them. There are 400 ways of filing the UB. You just happen to be lucky that only one child is a problem in dropping off of the payor's rolls.
But if you are a provider -- for instance, I live in Pennsylvania, but providers on the border of New Jersey and Delaware and Maryland have to be able to file claims in all three of those states. So you have at least four other ways of having to file a UB, and that is just one payor.
So there are those issues. I can also tell you as one who has followed diligently the implementation guides, because we needed to be able to do that in order to gather the statistics, I have seen a remarkable decrease in the one that was released in May of this year, over the one that was in November of the previous year and then May again of '99, I think. Each one of those successive implementation guides has reduced the amount of information.
In fact, we were talking that we used to use marital status as our example of the codes that got changed through the various ways that it was translated. Marital status is no longer required on any claim form -- excuse me, on any standard, period. The last one that it was required on was the enrollment form, and it has been dropped off of that now.
So I think you are on the right track, Kepa. And believe me, I know what consensus standards are all about. I have been on ASTM for longer than I can remember, so I know. I used to have dark hair before I started doing standards work, so I know what that is all about. But I think if NCVHS could do anything to help the process, if you went back to X-12 and asked them to go back to their group who developed the implementation guides -- I think you are on the right track, Lee, that people are ready to start saying, maybe we really don't need that, even though we have used it for X number of permutations. Have a concerted effort to go back and see what it is that is on these implementation guides that we absolutely, positively have to have.
On the provider side, it won't do us any good three years from now to decrease the amount of information that is going to be required, because we are already trying to send it. We have got to send that stuff in two years.
DR. BLAIR: Did Kathleen have something before me?
DR. FRAWLEY: No.
DR. BLAIR: I am trying to mentally reconcile not a major difference, but maybe a slightly different perspective that I heard. I am piggybacking on Simon's observations. So let me tell you what my interpretation is, and then maybe Don, Lee, Helene, you all could tell me whether I'm on target or not.
By the way, I think that all of you are doing just outstanding work, and your testimony has been just excellent. My thought is that WITI-SNIP has pretty much pulled together work, large payors, large health care institutions, major vendors, all of the folks that are able to consistently send representatives to WITI and to SNIP to participate in this process. It is outstanding work.
My thought is that the survey and the data that Helene pulled together was from a different portion of the marketplace. I am guessing, and you tell me whether you think this is on target, my guess is that of the 200 health care provider institutions that you surveyed, many of them were medium to small health care institutions, and they are not as well automated, they are not as well prepared, and maybe even some larger group practices, or smaller group practices.
If this is the case, then WITI-SNIP is leading edge, and you are hitting these issues faster than others and you are getting the data shared and moving on. Most of the folks that are engaged with WITI-SNIP are a little bit more ahead of the curve, and what Helene is tackling are those that can't move as fast. Is this perception right?
DR. SCHULTEN: Absolutely correct. I just want to give my perspective. About five, six years ago, I used to manage a rural health care practice in a small town outside of Richmond, Virginia called Amelia. This is a one-doctor county, this is how small this place was.
Whenever I look at these regulations and I look at these implementation guides, and I think about Dr. O'Connor and how he would try to meet these requirements, it is not possible for a physician in that position to meet these requirements.
You're right, what we are looking at right now the leaders of the industry who are able to participate in SNIP, who are able to come to these various conferences and send members. We do need to get more of a perspective from the small provider, from the rural provider community, so we can see what we are talking about here, and their ability to overcome these data content issues.
Your work on that, if you were looking at small to medium providers, is very useful. The only way that we are going to get that information as I see it is, we are going to have to do an outreach. These people don't even know yet what HIPAA is, so they are not even knowing where to turn to for information, because they don't know that they need to turn anywhere for information. We need to go out and find them, is my perspective.
DR. GUILFOY: As a point of following up on a lot of RFPs that we had sitting out in the hinterlands, somebody from my company just made a series of telephone calls to all of these people and said, we would really like to help you, what can we do. They said, we are not doing anything until the final regs are out. We said, the final transaction regs are out? They said, yes, but we are waiting for privacy and security.
I will tell you that this has not changed over the past year and a half. Denial is wonderful, it really is. Scarlett O'Hara lives, she is going to worry about it tomorrow, and that is where these providers are. They are just not worried.
Don and I were talking at the break; it is all well and good for the vendors to start to sit up and listen to all of this stuff, but they need to have some direction from the providers as to what it is that is going help them. That was part of my presentation. The data just ain't there, and they don't really care that it is not there.
DR. BLAIR: How could all of you maybe begin to work together? It sounds like you have both got a lot of helpful information to offer in different portions of the marketplace. Are you already starting to work together a little bit so that the leading edge folks and those folks that are smaller can make better connections?
DR. BARRETT: To answer the question, I have two points I wanted to make to your original comment. SMS is representing a fairly large vendor who has been engaged in this process. We did an evaluation of our systems in terms of completing the claim, and we found at least 60 data items on the claim that is called for in the 837 on the institutional side, that we would not be able to provide with our systems as they are today. So there is significant work in our systems to meet compliance.
Now, all those 60 data elements are probably not often required; it is situational. In those situations, when they occur, as has already been pointed out in the testimony, you are going to have to find a way to get that data.
So I don't think the issues that Helene was demonstrating in her statistics are that far off for some of the large vendors as well as some of the smaller ones.
DR. GUILFOY: The large providers? Yes, size is not a matter, is not a factor here.
DR. BARRETT: I also believe that these issues can be resolved.
Now, to the point of getting all the constituents to the table and trying to work through these issues, I believe very much that that is what SNIP is trying to do. Yes, the ones that come to the meetings are the ones that are better funded, and the ones that can afford to do that. But we have tried and are continuing to try to find ways to invite anyone to participate in this who can't come to the meetings by way of teleconference calls, by way of the audiocasts, by way of submitting issues to the website.
So we are creating methods for the smaller providers and the smaller organizations, the smaller vendors and the insurance health plans to get involved. I would hope that that will happen.
DR. COHN: Jeff, you need to finish up your question because others would like to talk also, but final comment.
DR. BLAIR: I just happen to have been involved in this state where I live, New Mexico, where they were very, very concerned about being able to be compliant with HIPAA. Larry Watkins was there, WITI and SNIP were there as well as others, to help them understand this.
My suggestion is that -- and maybe other states are doing this as well -- is that states are pulling together payors, providers, as well as the Medicare folks that need to be involved. They are another part of the alliance that may help to reach out to these smaller institutions to be able to bridge the gap.
DR. COHN: The final quick comment, and then we'll move to other questions.
DR. BARRETT: I'll make one quick comment. Taking these regional efforts that I talked about are reaching out, working with the states, and leveraging the state efforts that are going on.
So Jeff, your point is well taken. Also, the other thing that we are doing is, the educational group that we have got is taking outreach, working with the individual providers as well. That is going to be a way in which we can get the word out.
DR. ZUBELDIA: I have two questions, just one now, and then if we have time, we will talk about the other one.
This keeps coming back to me, when Helene said, the data ain't there. The data ain't there, but the claims are being paid today, the transactions are going through today.
DR. GUILFOY: With paper attached.
DR. ZUBELDIA: And today there is a request for additional information that supplements when the information is not in the claim. So this may be a revolutionary idea, but -- and I have the disadvantage that I have seen how the standards were made over the last 10 years, 11 years, and I have seen how implementation guides were written. I participated in it, and that is a disadvantage.
I know that when somebody comes to one of those meetings and says, I absolutely need that piece of information, it must be there, even though it is only entity that needs it, it gets included in the implementation guides. It is a required data element.
We are still thinking with the open loop mentality, where you get one shot to send your claim in and get it right, because if you don't get it right it is going to be denied, and you have to do it right the first time.
I remember when we had the first draft of the implementation guides three or four years ago. We received the reaction that there could be no optional elements. Everything had to be either mandated or with a specific situation defined. That again has the open loop mentality.
Helene was saying that the marital status is no longer part of any of the transactions. I found out immediately that yes, the payors require marital status in the enrollment. Well, some payors do, some payors don't. I would say all payors do. But why don't we go to a closed loop, where HIPAA allows with this transaction set that we have today to have a closed loop, where you can send a claim, you send the claim with missing information, there can be a claim status inquiry coming back from the payor requesting the additional items of information. Now we can with the closed loop environment have optional elements. It is the option of the submitter to submit with the claim or put up with the request for additional information and submit it later. But if you don't have it, you can send it without it.
DR. COHN: Kepa, I don't mean to break in, and I'm sure they are able to comment, but remember, you are talking to the wrong audience probably for this discussion.
DR. ZUBELDIA: But in their experience, is this something that can be done, or are we too late in the process to go to the closed loop environment?
DR. BARRETT: Never too late. The point is, certainly it could be done. But I think the issue comes down to, it would require a significant change in the way in which payors and others do business. But there is nothing that precludes, Kepa -- you could get down to the claim attachment which we have been working on. There is nothing that precludes that if the payor came back and said, if these elements are missing, just provide this additional data, and we could utilize the claim attachment or some other form. There is no reason that that couldn't be done and have some type of tracking mechanism to track it back to the claim.
The answer is, it can be done.
DR. ZUBELDIA: Without doing that, are the implementation guides that we have today implementable in two years, if people don't have the data?
DR. GUILFOY: Just simply to change the implementation guides for the claim status, you are still going to have to have the data, because if they come back and ask you for the data, you are still going to have to submit it. Either it is pay me now or pay me later. If you don't submit the information, they are still going to have to come back to you.
The other thing that I would point out in something like that is, if you want to get the hospital's attention, that may be the way to get it, because that is going to dramatically increase their days in AR. That would just shoot it through the roof. One of the reasons that hospitals are embracing HIPAA is because we can get all this information out, they can't slow us down on the payment, et cetera, so the days in AR are going to fall back. You are talking about looking at places that are looking at 80, 90, 120 days in AR. Goals in hospitals are to get days in AR down to 50 days. That is a lot of days to have money sitting out there.
DR. MC DONALD: Maybe it has been already spoken, but I was going to support Kepa's original comment that there is the risk in the consensus that to get done, you accept the pile-on, so you have more things. Some are screaming and yelling, you want to get home, so you might tend to accept more elements than you would otherwise.
I think it might be reasonable to do one last severe surgical look at what is required and what is not to ease the implementation. Like, the two you mentioned seem like, why would you need them, from what you said.
DR. GUILFOY: This is scary. I agree with Clem and Kepa; somebody write this day down. But that was basically what I was saying. If the committee were to give any direction, I would suggest that the direction be given to go back, and let's take one look at the implementation guides, along with the people that developed them. You can't do this in a vacuum. Do we need to have all of that information.
But I would say that if we are going to do that, we have got to do it quickly, because --
DR. MC DONALD: Do we count the dimples?
DR. GUILFOY: Yes.
DR. ZUBELDIA: It is always easier to release a requirement.
DR. GUILFOY: Absolutely. But the concern that I wanted to make was that the timetable for the vendors will allow the providers to collet all of this information. Even if they change the systems to allow us to collect the information, we have still got an implementation cycle to go through. To implement a new release of a major HIS system usually is between four and six months, to implement a new release.
So that means that in order to have this thing implemented by October of 2002, we are going to have to have the software in house by March of 2002. If you look at New Jersey, you've got to have it even sooner. So the timetable is scrunching down.
But I would strongly suggest that if there was any direction given by NCVHS, it is to go back and look at what those implementation guides are requiring, and starting with the ones that are the biggies. We can't do without claims.
DR. FRAWLEY: Helene, I had a question on one of your slides. I may have missed something. On the one that is the medical data code sets, page four, diagnosis codes, you have a range of 25 to 43 percent will be able to collect ICD-10 CM. I was trying to figure out where you came up with that range.
DR. GUILFOY: What we looked at was, if they have six positions or seven positions that they could store. Normally HIS systems store six positions, three dot two, so they store the six positions. If you put a seventh position in there, which is the three dot three, that is what ICD-10 3M will be, they can't store it, most of them.
Some of the systems, that is where you get the variance and the numbers, but the majority of systems are not capable of storing that larger size.
DR. FRAWLEY: Then on the procedure code, you have 32 to 75 percent.
DR. GUILFOY: Yes, and that 75 percent blew me away.
DR. FRAWLEY: It is just the variation, the percentage shift.
DR. GUILFOY: Understand that what we looked at here was primarily the clients answered the questions and they told us what they had. What we asked time and again was, don't tell us what you currently use, tell us what the potential is. So if you have a programmer go in and actually look at the code, it was as reliable at the information that we got back.
What generally for a procedure code people are storing right now is a five-position CPT. So I don't know where we're going to get seven positions for the ICD-10 PCS or more importantly, for -- one of the things that we know we're going to have to have in October 2002 is NDC. Where are we going to put it? Are we going to put it in the patient account record? We can't put it in the CDM, because it can change.
There are all of those issues that need to have discussions between the providers and their vendors. The vendors need that direction, but before they can get that direction, the providers should be aware that they've got a problem.
DR. FRAWLEY: Right, that is the key point, that the providers need to understand that they have a problem. They don't know yet -- a lot of them don't know yet that they have a problem, so they are not asking their vendors to step up to the plate. So we might have to go around the providers to get to the vendors and put that in there, and the provider is still oblivious, I don't know why I have this new field.
DR. GUILFOY: As far as the providers are concerned, their approach is, this software doesn't belong to me, I'm going to count on my vendor delivering the compliance software. So they are really sitting back and not doing anything with it.
DR. COHN: I'll follow up on that in just a second. Betsy, did you have anything? Then Tom Gilligan I know wanted to make a comment. We need to begin to move on, because we're going to be here until 8 o'clock tonight otherwise.
DR. FRAWLEY: You will be. We won't.
DR. FITZMAURICE: This maybe will tie in a little bit with Tom's comment. I notice in the statement of Lee Barrett, he mentioned there is considerably concern in the industry regarding the fact that there is not enough time to complete all of these implementations.
Today I have been very impressed with what WITI-SNIP has been doing, with what AFECTA has been doing, with what Helene has been doing to gather the information, assess what the problems are, and these groups are formulating plans for addressing them. So I'm not sure if I have a false sense of hope or security, but I think it is much too early for me to form an opinion. Maybe a year from now when people have finalized some solutions and tried to implement them, we will be in a better position for this.
So I would share the concern that the industry has, but would want some more concrete facts about how long it would take to do it. As you are just now identifying the problems and formulating solutions, it sounds a little bit premature to me. Do you have a comment you would like to make, Lee?
DR. COHN: Can Tom make his comment, since you are obviously asking a question directly on that point?
DR. FITZMAURICE: All right.
DR. COHN: Tom, do you want to come to a microphone? Just indicate who you are and who you represent.
DR. GILLIGAN: I am Tom Gilligan, and I represent the Association for Electronic Health Care Transactions, which is comprised of quite a bit of vendors; we have got a vendor focus. We also have payors and one or two providers.
I am listening to this today. I did notice in Lee's comments the thing about the concerns for time and implementation. I am starting to see that being echoed up on Capitol Hill. I am starting to hear people ask for legislative changes to say we need this much more time. That gives me quite a bit of concern, because as they open up the legislation to change, the two to a three to a four, that means they open up every bit of it.
I guess what I am here to do -- one of the things I would like to do today is lay on the table for discussion of you all as to what kind of flexibility the Department could exercise or what kind of flexibility this committee could suggest that the Department exercise with respect to the application of enforcement and penalties for non-compliance at the current compliance date, which is October 2002.
It may be very helpful if we can't identify it, we are going to be ready by thus and such a date to have HHS in a flexible mode to not assess penalties against organizations that are demonstrating a good faith effort to comply with the HIPAA transaction standards.
The other thing I will say is that I heard the early drumbeats of people trying to decide, is this a vendor problem, is this a provider problem, is this a payor problem. It is my hope that we don't throw that away, that if we start to identify problems, it is not going to be just a vendor problem nor will it just be a payor problem. I hope we get down to a much deeper level of detail when we start assessing where the problems are.
I think that completes what I had to say.
DR. COHN: Mike, do you have a comment?
DR. FITZMAURICE: Just to respond a bit to Tom's questions. I don't speak for the Department right now on this, but it seems to me that the law is fairly clear, that once you accept the time deadline, you accept the time deadline.
On the other hand, the law gives the Secretary plenty of leeway in terms of enforcement and in terms of providing technical assistance. I suspect that the people to make those decisions are not yet on board. Then again, it would be premature for me to say something on this, but the next Administration coming in may want to have that issue raised.
DR. COHN: Let me make a comment, and then I'll let the panelists also comment. One would observe that the enforcement and compliance NPRM has not even begun to be discussed yet, so some of the issues you are talking about in enforcement and compliance probably just needs to be viewed in relationship to that.
The other thing I am very aware in terms of the legislation is that there is some ability for the Secretary to modify the final rules the first year after acceptance. One of the things that I think we are all talking about is mitigating issues around implementation. I don't think anybody here is saying stop implementation, but are there major issues that we need to do something to mitigate.
I think that is what you are describing and framing here.
DR. GILLIGAN: I am hearing today another discussion about what may be another reason why we as a collective people, everybody interested in HIPAA, may not be able to make the deadline. As these things start to come up, my concern starts to grow deeper.
DR. COHN: Comments from the panel?
DR. BARRETT: Simon, one thing I wanted to say. One of the things that I will tell you, by February of 2001 is to identify all of the issues that are swirling around, identify those issues, quantify them, determine what is valid, what is not, make a set of recommendations in relation to what is discovered to a number of constituencies, NCVHS, others, in relation to key recommendations that WITI will in fact look to bring forward.
What we are trying to do is, we are trying to cut through -- to put it bluntly, cut through a lot of the issues because as Tom is saying, he is hearing a lot of things, a lot of people are hearing a number of different things. What we are going to try to do is, in our role in trying to assist with facilitating in collaboration and coordination, is to look at these issues, determine what is valid, and come up with a set of recommendations by February.
We feel at that point we've got a new Congress that will coming into place. There will be a new Administration, and at that point we feel we need to react sooner rather than later. So what we want to do is be proactive. We are going to be in fact trying to work with a lot of the key organizations to identify those issues and bring those forward.
I think it is a major concern. It is a concern that is out there. We want to make sure that the issues are valid. If there are some, we want to identify them.
DR. COHN: Lee, let me just ask, the next hearing for this subcommittee is February 1 and 2, and we are going to be meeting at that point with the DSMOs. Is this something that would be -- I don't think it is ever going to be done, but would there be a product at that point?
DR. BARRETT: Yes, we'll have a product by that meeting.
DR. COHN: Thank you. Other questions, comments? Betsy.
DR. HUMPHREYS: Just a couple of brief comments. I feel that whenever you are contemplating a major change involving as many players as this, there are going to be a lot of issues. I applaud your view of which ones are real.
Obviously, if you have to change a system, whether you change it to add 10 elements or 15 is perhaps not the biggest issue. You have to change the system.
So I think that it is likely that systems that are not compliance already, of which there are probably very few, will have to undergo some change, or we won't achieve any of the benefit of HIPAA or any party that could achieve a benefit. Therefore, systems will be changed. The issue of making a few more at the same time, or a few fewer, obviously you can have degrees where some of these represent a huge degree of additional work, but a lot of them are just part of the fact that you have to change the system. That has at least been our own experience in replacing large systems.
The other issue that I wanted to get at in terms of your presentation of the last speaker, I really applaud this notion of looking at these forms and saying, how close are they. But am I correct in assuming that the end goal here would be, give the people a different form that was compliant? I really don't understand why we would go forward to implement HIPAA, and think that it was a reasonable thing for a whole bunch of people who are going to collect data on a paper form to use a form which will never be compliant, will require them to do something totally different, where we will never get the correct data except by elaborate conversions.
So I can understand the transition, I can understand many things, but I can't understand a long term future with people using the form if they have to use one which is not compliant with the standard.
DR. SCHULTEN: Right. The NUCC originally undertook this study because they were looking at the time to change from the HCFA 1500 form to a new form. When they were trying to have that form mirror as closely as what it could to the 837 implementation guide, as it was at that time, I think they were coming up with some two-page form with a print type of this big, and they were like, this is ridiculous; why are we trying to make this form match that.
The other issue too is that many provider organizations who have these systems that are making this HCFA 1500 form, they do send that data in an electronic format to clearinghouses. So even though it starts off and it can make a paper form, more often than not lately, that stuff has been going electronically. So how do we include those providers in the HIPAA world so that they can continue to send their transactions electronically, if they are used to using the HCFA 1500?
The other way is that they have to send it now to paper instead of electronically, and then mail it.
DR. HUMPHREYS: I guess I consider this part of the overall HIPAA. It is no different for these people than it is for everybody else in these systems. Whereas there may be various timetables that you would do this, it seems to me that I am having difficulty feeling that the preservation of these other approaches over the long term is the way to go. That is my comment.
DR. COHN: Let me make a comment. I am a member of the National Uniform Claims Committee, representing the American Association of Health Plans. I was involved in a couple of the discussions around what it is you need to modify the HCFA 1500 to the HCFA 1600 or 1700 or whatever number you want to call it.
At the time there was a survey done of the health care industry -- by the way, Kathleen Fyffe is also a member there, but there was a survey done, and there was a significant amount of resistance by the industry to adopt a new form. Hence, the question was, how far can you get along with this form, or if you are a payor and you get something in on a paper basis, and your systems are set up to accept the 837 and your database is set up to accept the 837, what do you do. I think that was the logic behind this.
I guess the answer, at least from what I would assume from you, Kathryn, is, kinda. Is that the answer with the 1500 evaluation?
DR. FYFFE: Sorta kinda. I think the effort to do the comparison seems to be very laudable and absolutely essential.
DR. COHN: I am hearing that you think that maybe the group that is responsible for that form ought to go back and --
DR. FYFFE: Wait a minute. If it is not used for an electronic transaction, then it is not covered by this.
DR. HUMPHREYS: Correct, and if providers don't want to send transactions electronically, they can do it on paper. Payors on the other hand have to be prepared to accept the HIPAA 837 as well as the paper. So is it administrative simplification for payors? Maybe, maybe not. It depends.
DR. FYFFE: Well, we certainly heard a lot of comments in a variety of areas coming in and saying, please just apply the HIPAA transactions across the board, even if people are submitting data on paper, which clearly is not what the law allows for, but what a lot of people said would be true in administrative simplification.
DR. COHN: Any final questions on this one before we move on? Kepa? I want to finish off this section.
DR. ZUBELDIA: I have a question for Lee. What about the Internet? Is WITI-SNIP going to look at an implementation plan for implementing health care over the Internet as part of an overall implementation plan? Or is it only going to deal with the transactions?
DR. BARRETT: It is going to deal with the transactions, Kepa, but at the same time it is also going to look at the Internet. As I was talking about in my testimony, Internet will be -- we have a specific group, sub work group, that will be working on the Internet component. So yes, it will also be evaluating the use of the Internet as well.
DR. GUILFOY: Kepa, just as a plug for WITI-SNIP, there is also a group that is looking at developing screens for the direct data entry. I happened to participate in a work group myself, because there is a whole lot of institutions out there that, they may not send it electronically, but they have got a little CRT sitting in the back of the business office, and somebody corrects the data on that screen, that information is going to have to be compliant with HIPAA. There is a sub work group out of WITI-SNIP that is looking at that information.
Nobody is even talking about that yet. That is another whole issue that the providers have to sit up and take notice of.
I want to just echo what Tom said. This can't be an us against them situation. All three areas have got to work together to reach a happy conclusion on this.
DR. COHN: I want to finish off this conversation by observing that this is obviously our responsibility to follow this along. We really appreciate the panelists for helping to both spotlight some issues as well as work with us to try to come up with reasonable answers.
Any implementation I have ever been involved with has been a rocky implementation, and there are always pieces of buyers' remorse and everything else, next day is next week, next year. But I think we all need to be dedicated to making this the best implementation possible, as well as observing and trying to correct any issues that come up with the implementation.
Obviously in February we will be talking to the DSMOs. I am hearing that we ought to be talking to them about a variety of issues, not just the website, but hopefully also the implementation guides and the status and just reviewing all of that. But we also need to be hearing from other groups about issues that are coming up as they look at the providers.
I have also heard that in all of our discussions -- obviously Elaine brought up some issues in July. I am actually not hearing anybody at the panel or elsewhere saying that there is anything fundamentally wrong with the data, which is actually one of the questions that I had when I looked at it. There seemed to be such a disconnect between the data that she was reporting and what seemed to be industry -- what was going on, that I wanted to reconfirm that.
So I think that is some of the issues we need to discuss with the DSMOs also, as well as the vendors. I do think that it is the responsibility of the vendors to produce HIPAA compliant products. So a doctor -- I spent a number of years practicing in a small town in West Virginia, and if I were back in my practice, I wouldn't be looking through HIPAA implementation guides. I'd be looking for my vendor and say, is this next version of software HIPAA compliant, and I would want to depend on them that the answer was yes.
DR. BLAIR: Simon, one of the things that may help us when we have the vendors here is, the issues that Helene has identified in terms of capabilities of vendor systems that may be part of the questionnaire, but I think there are other organizations also that could help us with questions. So when the vendors are speaking to us, they are beginning to address their ability to deal with some of that, things that Helene has identified and I think that maybe Kathleen has identified and some of the others. So I think we have got a lot of good information that can help us come up with meaningful questionnaires to ask the vendors.
DR. GUILFOY: But let me just reiterate again, I think the point that Kepa brought up and that Clem echoed, if we could take one more look at the implementation guides, and do we really need all this information.
I think far and away, that would help to smooth this thing out more than anything else that any of us sitting here could do.
DR. COHN: Final comments before we move off this issue?
DR. MC DONALD: I wanted to emphasize the same point. One flash point in this could be -- and we are talking about, everyone is going to agree and be happy, but when you have required elements, the claim would be rejected if they are not filled out. That is thought by the physician's side often as a happy event for payors. We know it is probably not really.
But what this really could do is have a fire, in the sense of a revolt, on the provider-physician side, if we are not really careful about these required elements.
DR. ZUBELDIA: I wouldn't see a problem with requiring the provider's specialty, because that is going to be already coded. It will be plugged in and it's fixed. I don't see a problem with that.
The problem in that area is for the clearinghouses that are going to have to plug it in, because they can't easily plug it in. So it is going to force the providers to migrate to the HIPAA transactions, and they may not be able to take advantage of the clearinghouse, and it may end up being a little more expensive up front.
DR. GUILFOY: The taxonomy could be a part of the NPI.
DR. COHN: Anyway, I think we will continue this part of the discussion. I don't think we are ready for a letter that would have substance to the Secretary, plus with the transition occurring in the government. But hopefully by the first and second, we'll have a new President, a new Secretary of HHS, and it would at that point I think be reasonable to begin to be able to see if there are any recommendations we need to make.
Targeted to the DSMOs, I guess I would worry that in the midst of an implementation, if we start getting major changes in direction to the industry, it would be very counterproductive. On the other hand, if there are things we can do to help ease -- or that the DSMOs can do to help ease the implementation, I think that would be well accepted and appreciated by all.
So we are in the midst of implementation now, so we need to have that responsibility.
At any rate, with that I want to thank our panelists. Obviously we will talk about this towards the end of the session today, as we reflect on what we need to do in February.
We are 40 minutes late -- surprise -- but Kepa, I think the next agenda item has to do with digital signature standards. Kepa, do you want to talk about digital signatures a little bit?
DR. ZUBELDIA: After the meeting that we had here a month ago on digital signature, the hearing we had, I sent an invitation to the chairs and co-chairs of the standards-setting organizations that are involved in the implementation guides and the HIPAA transactions.
The invitation was for them to get together and come up with some agreement on electronic signatures, and something that could be useful for all of the standard transactions that we know today and the ones that we expect.
The response has been very good. The NCBDT had a meeting two weeks ago in Kansas City and they formed a new task group under their security and privacy work group to address electronic signatures. HL-7 is very actively working on some method of electronic signature that could be adopted as a standard.
Peter Wegemann is going to hold an HISB meeting in Phoenix next week, in which the DSMOs will participate and coordinate their work. HL-7 is going to have a meeting in Orlando, I believe, on January 8, some sort of super Monday, with all the DSMOS involved in electronic signatures. DSMOs and other standard setting organizations, ASTM, probably IEPF, some of these entities that have their own digital signature standards, or electronic signature standards.
The idea is to coordinate among the standard-setting organizations the recommendation or the adoption or the creation or whatever is necessary to have an electronic signature standard that will be applicable to all the HIPAA transactions.
I have been following their efforts, and I keep trying to limit the scope to what we need in a very self-serving way. I am asking them to come up with something that could be adopted for signatures of HIPAA transactions, and not dilute their efforts into trust issues or PKI or other related issues that are very important, but they don't address the issue that we need to address right now.
So the progress is going very well, much better than I thought it was going to be. I thought it was going to be a big fight. Instead, they seem to be working together and are very eager to work together and come up with something. We will see some results probably by the January 8 meeting in Orlando, when everybody has agreed to be there in a technical discussion.
Next week in the HISB we have the leadership discussion and the agreement to work together, and in Orlando they will have a technical discussion as to how to do it.
So my recommendation would be to have some report from the Orlando meeting in our February 1 and 2 meeting, and let them report as to what they have done and what sort of consensus they have reached or not reached. Hopefully we may have something that could be adopted as the electronic signature for the HIPAA transactions.
DR. COHN: Do we clap? Actually, we should probably hold off and wait for success until we start clapping. Comments or questions?
DR. FITZMAURICE: Question, Kepa. Will this list be an American national standard?
DR. ZUBELDIA: Mike, that is an excellent question.
DR. FITZMAURICE: Well, thank you, Kepa.
DR. ZUBELDIA: That has been one of the debate points. There is currently two standards that are a candidate to be adopted by this consensus group. One is the ASTM E-3117 set of standards. They have a standard for a digital signature for health care. But ASTM is not ANSE. ASTM is at the same level as ANSE.
DR. FITZMAURICE: I beg your pardon?
DR. ZUBELDIA: ASTM is not an ANSE accredited standard.
DR. FRAWLEY: ASTM was given recognition about three years ago as an ANSE accredited standards development organization, and all of the ASTM standards are ANSE accredited. The standards on digital signature and the other companion guides that came out of E21.20 are all ANSE accredited standards. That information was very clearly communicated to the Department, and the notice of proposed rulemaking was published on security two years ago. ASTM is very clearly ANSE accredited.
DR. MC DONALD: Could I clarify? ASTM E-31 is ANSE accredited, and it wasn't when the HISB process started, because they had a disagreement with ANSE, just to clarify the different views. All of ASTM I don't think is an ANSE deal.
The standards are not ANSE standards. They don't submit them to ANSE as IEEE and HL-7 does, but that doesn't matter in the law. It is just that you are an ANSE accredited standards organization. So it is kind of complicated.
DR. ZUBELDIA: Thank you for the clarification.
PARTICIPANT: (Comments off mike.)
DR. MC DONALD: I think their process has been deemed by ANSE as an acceptable process, and so the standards that result from that process, that ANSE accredited process, are American national standards. They have to publish them by -- that is something new then. But that is not really relevant to this whole discussion.
DR. FRAWLEY: No, it is relevant, because the problem that we have is -- we had a meeting in October, we had some discussions involving the ANSE accredited standards organizations, and then we are going out and saying, one organization is not ANSE accredited, and we did not even send an e-mail to that organization inviting them. So I just want to make sure that everybody understands, they are ANSE accredited.
DR. MC DONALD: I'm trying to distinguish between ANSE accredited organization and ANSE standards which ANSE has to be able to publish. But it doesn't really matter if --
DR. FRAWLEY: But that was worked out over three years ago when we were at the Opryland Hotel in Nashville. Those details were all worked out with ANSE, in terms of publication of the standards. There is clearly no issue in terms of a, the publication of the standards, and number two, the fact that ASTM is an ANSE accredited standards development organization that meets all of the criteria, as does HL-7, X-12 or any of the other groups.
So I just raise that because of the fact that we discussed at the October meeting that we would invite all of the SDOs and ASTM was not invited.
DR. ZUBELDIA: I'm sorry, ASTM was invited.
DR. FRAWLEY: You sent out e-mails, and I was cc'd on them. You invited Dan Stannuck from NCPDP. You sent a letter to HL-7. You made some passing references in your invitation to ASTM, IEEE and some other organizations. A communication did go to Peter Wegemann as chair of ANSE HISB, but there was no concomitant communication that went to ASTM.
I raise that, because at every meeting here -- and I think we have to be very clear and I bring this up all the time, about people being sure they identify their conflict of interests and their dualities of interest. ASTM needs the same consideration as every other SDO. We have problems at this subcommittee where we treat them as if they are a stepchild, and that their standards are not at the same level of acceptance.
So I just go on record, because we talked about it at our October meeting, we went out the same night and sent out e-mails. I received them, and there was no invitation to ASTM.
DR. ZUBELDIA: Kathryn, let me point out that I went personally to the E-31 meeting in L.A., and personally met with Peter Wegemann and Tracy Sinroskia and Claudette Escier and -- not Tracy, Tracy's replacement -- and invited them to participate in this. I took that step to do it personally. It is the only SDO that I have gone to a meeting personally to invite them like this, because I want to make sure they don't feel left out.
DR. COHN: Kepa, just to make sure that I understand. My understanding is that there is a meeting that is planned in January that includes ASTM as well as the other standards organizations, to see if there is a consensus recommendation.
DR. ZUBELDIA: Yes, and at the HISB meeting next week, ASTM will be presented and represented. They have been asked to participate in this.
Now, I hope that they don't feel left out, and I will continue to invite them personally, but I will also include them in the e-mails, in spite of the personal invitations.
The representation that was made to me in L.A. about a month ago was that ASTM was not ANSE and their standards didn't go through ANSE. That is why I made this comment here, and I am grateful for the clarification.
DR. COHN: Obviously you have been corrected.
DR. ZUBELDIA: I am grateful to be corrected. So there are some issues, whether the standards go through ANSE or not. As Clem said, that is probably irrelevant, because it is an ANSE accredited standard setting organization, even though their standards may not be published by ANSE.
The other potential candidate for electronic signature is in a similar situation, because they are looking at an IETF developed standard and Internet standard called EDI-Int that has been -- it is still in the development process within IETF, but it has been adopted as an implementation under HL-7. So the standard was created by IETF and then adopted by HL-7 as their security mechanism. Now they are looking at maybe HL-7 adopting that standard as an HL-7 standard, so it can be an ANSE standard. Maybe Clem can give us more light on that.
DR. MC DONALD: I don't really know more than what you just said. This whole business is really pretty easy because there are just a few little buttons you have to touch to make it fit a particular need. I don't know how it will all play out.
I think it is also ASTM complaint. There is a difference, because the IETF one is fine in terms of bits and bytes that runs a real message. The ASTM one is defined as rules to be followed, and I think they may just fit perfectly on each other and this could be a very happy outcome.
DR. ZUBELDIA: Hopefully that will be the best outcome, where they can agree with the ASTM rules and the bits and bytes of IETF under HL-7 and come up with something that can be adopted. That is the purpose of that meeting in January, to resolve all those technical issues.
DR. COHN: So we will hope for a report as well as -- it would be great if there were a consensus recommendation. If there isn't, we'll deal with that. But it would certainly be useful.
DR. MC DONALD: IETF is the Internet Engineering Task Force, for those who don't know the acronym.
DR. COHN: In terms of next steps about that, I think that sounds great in terms of February. Do others have other views of anything that needs to happen between now and then?
DR. ZUBELDIA: One of the issues that are still needing addressed is, they didn't ask to come up with an electronic signature standard. The thing that has been under discussion in the last couple of weeks is, what is the point; is this electronic signature to represent the intent of signing a transaction, or is it just a security mechanism to provide integrity in the transmission of transactions?
I think the standard setting groups would like to have some clarification on that aspect, maybe from the Department, to help them understand what is it that the intent is.
DR. COHN: Who would you like to receive that clarification from?
DR. ZUBELDIA: It would be nice if there can be a clarification by next week in Phoenix, so the leadership can take that to the work groups and say, this is what we are supposed to do.
DR. COHN: Is there a question? Come to the microphone and introduce yourself.
DR. RUDIE: Dan Rudie from AHIMA. The issue that has come since your last meeting on this, and without the privacy rule it is kind of hard to tell, is that in using the eligibility and some of the other standards which we unfortunately many times right now do not require authentication; hi, I'm Susie, I'm from this hospital, I need information on this patient, or I am from this insurance company, I could use a little clarification on this claim.
While this has been done a lot in the verbal transactions that occur, as you go into electronic transactions, as you go into security and privacy requirements, while they may not need a signature as we know it, the authentication of the person that is making that transaction, creating the transaction and asking for information back, becomes significant.
It is probably something that should have been there all this time, but as we go into the security and privacy requirements, it will become almost an immediate need, as we move these transactions to an electronic basis. Should I accept the electronic transaction or respond to it with a 271? How do I know who that person is? We are talking now of authentication of everybody down to the entry level clerk in the admissions office. If I am in medical records, how do I know that the person requesting this record has that authentication?
We have a lot of those kind of issues that could face us very quickly, depending on the nature of the security regs, and would prevent us from using electronic transactions if we don't have that somehow incorporated into this at some point.
DR. COHN: It looks like Clem has a comment.
DR. MC DONALD: I may be projecting what Kepa was leading to, but as I understand it, it is fairly easy technically to do a verification that this came from the computer you thought it came from, using the security and the various technology to do that.
We are probably nowhere near the ability of that computer to look out and make sure it is really Simon Cohen doing it. It is a tough problem. I think it may take a lot longer to solve that, and the biometrics will probably have to be in place before that would work well.
DR. ZUBELDIA: The question that has come up recently is, if the intent is authentication, then the digital signatures as we know them today can provide authentication, as long as there is an authenticator, some sort of certification authority.
If the intent is to legally bind a person to a signed document such as a prescription, then you need to know what is it that you are signing. A machine signing on your behalf doesn't necessarily provide that kind of assurance.
So depending on what the intent is, the solution would be different. I have asked them to center on electronic signatures for the HIPAA transactions, knowing that none of them need a legally binding signature today. But the security final rules may require those transactions to be authenticated.
It is still a little confusing as to what is the purpose of the electronic signatures under HIPAA. Is it authentication or is it to express the intent and the assertion that this service was rendered by a specific physician, or what is that intent? That needs to be clarified.
DR. COHN: Kepa, the question I would have on this one, and I certainly wouldn't try to answer it, but it occurs to me that we do all talk in the future about having the standard for a prescription. I would sure hate to do a standard that required everybody to implement a particular electronic signature standard that then had to be completely pulled out and something replaced, if we moved a step or two in the direction of something that does require authentication.
So as I say this, I guess it would be really nice if there was something that could be built on -- a foundation that then could be build on. Thoughts or comments?
DR. ZUBELDIA: And that is the kind of direction that they need to get from the Department; is this something that is for the future, or is it just an authentication mechanism for today's transactions? I think that would work either way, and they may find a solution that works either way. But I think they need to have clarification as to what is it they need to do.
DR. COHN: Comments otherwise? Well, we will continue this one in December, and perhaps the Department can provide additional clarity as to what would be appropriate.
DR. FITZMAURICE: Can I make sure I understand the question? The question is, is the purpose of the digital signature to authenticate that the real life person who is associated with this particular signing? Or are you asking, is it to associate this particular signature with a given document? Or thirdly, is it to guarantee that the message remains the same in the signing by the person and your receiving and opening it by Kepa?
DR. ZUBELDIA: Yes and no. Digital signatures today can be used to express several things. They can express the integrity of the document, making sure that one has not been changed. You can express the authenticity of the signer, and whether the signer is a person or a machine. You can bind that signer, person or machine or program, to a specific document, even with a time stamp.
But neither of those would be appropriate for a prescription. In a prescription, the signer has to know what is it that they are signing, and has to agree with the content.
So for instance, in some states, in Louisiana until very recently, the claims had to be signed by the physician and notarized, and that signature meant, I have rendered these services. It had nothing to do with the document being secure and authenticated. It was an assertion of rendering the services.
If somebody were to affix a digital signature to a claim transaction, what does that mean? Does that mean that they certify they have rendered the services? Does that mean that they certify the translator has given an accurate representation of the claim?
DR. FITZMAURICE: Doesn't that require that an explanation of the signature be part of the document?
DR. ZUBELDIA: Yes.
DR. FITZMAURICE: So all that is really required is the authentication. If I really signed the document and the document says that this guarantees that I did the services or that this is a prescription, then they are one and the same. If it doesn't have a meaning for the signature, then the signature may have no meaning, except that you presume that it is me, because I am authenticating that it is myself.
DR. ZUBELDIA: So the documents today, the standard transactions do not have any of those explanations. So what is the meaning under HIPAA of a signature on a standard transaction?
DR. FITZMAURICE: It's not required, so it doesn't have a meaning.
DR. FRAWLEY: That is just what I was going to say, is that none of the current standards, transactions, require a signature under HIPAA. But my concern is that any work that we do in the area of additional signature standard will become the de facto standard for authentication of medical records, prescriptions, other types of transactions.
So I think we have to be very, very careful in this area, because currently none of the transactions require a signature, but there are other transactions that take place in health care that do require a signature. So people would look for guidance in this area.
Right now, there are vendors who have these tools for electronic authentication of patient information. Actually, all it is is affixing an ID number. It has absolutely no integrity at all. Anybody could affix the ID number, and it would certainly not give you any of the attributes that you would be looking for.
So I guess it really does raise the question of, what are we attempting to achieve.
DR. COHN: To my view, rather than the characteristics that Kepa is referencing, I tend to think, which standards would I want it applied to. I am much more simplistic in this view. I agree with you, Kathleen, I don't think there is a requirement, though maybe with some security regs or privacy regs coming up, there may turn out to be something that gets required, but certainly doesn't appear to at this point be a requirement for digital signature for the current HIPAA regs. But if we were to think about a prescription as a HIPAA standard that may come out in the future, or a PRMI standard, the next generation of HIPAA pieces, I think if we are going to go to the effort at this point to come up with one, it should in some way fit or be extensible to fit without major re-engineering.
I guess that was my thought on this one. I am looking around, I am hoping I am not caught in a major sea change from your view on this one.
Michael, help me with this one if you think we are -- you don't need to clarify it with the Department.
DR. FITZMAURICE: I think the HIPAA law itself states the requires of a digital signature. I'm not sure if it is integrity, certainly it is authentication. There are two or three specific words that are required. It doesn't put it into the context that Kepa is looking for, but I think it is sufficient that it addresses the context that Kepa raises and you referred to as well. We are building something for the future, since nothing in existing standards require a digital signature.
DR. ZUBELDIA: In my conversations with the SDOs, I pointed out that what we are looking for now is a signature for the transactions. If that can be used later on to authenticate medical records or for prescriptions, that would be ideal. But if it cannot, and there are additional requirements for prescriptions for medical records, let that possibility be. If we need to have more than one mechanism for different scopes and different purposes, that is a possibility.
If all we need now is authentication and integrity, maybe what we need is a very simple digital signature that gets applied by the translator or by the machine automatically. Maybe that is all we need now. If what we need is authentication of a medical record or a prescription expressing intent of the signer of some sort, then we may need a different solution later, or maybe the same solution can be expanded later.
That is why I think they need some clarification from the Department as to what is the intent of those signatures today as we know them.
DR. FITZMAURICE: I think the best thing you can get from the Department is a re-reading of what the law requires. Since we don't have a standards working group in place, we don't have an answer for that. I will pursue it and I will try to get an informal answer, but since none of the HIPAA standards require a signature, you can put anything you want on them.
DR. COHN: Kepa, just to further clarify, and maybe I have said this 12 times, but the legislation does say these standards and other standards that the Secretary may decide that support administrative simplification. So the question gets to be, what sort of standards could you imagine over the next couple of years that might support administrative simplification that need an electronic signature.
So to only look at the 10 that are identified there, I don't think you are going to get much help when you go to first report of injury, and I don't know what claims attachment will do in relationship to that.
DR. MC DONALD: I'm not at all an expert on this, but I think that we assume more of technology than it necessarily deserves, often. I don't think that there is a solution in the purest sense for the electronic signature as we apply it to a prescription.
Say if someone sees something on a screen, there is a data structure in there and it has a signature to it, then it can't be converted into a standard transaction, because it is all locked together. And you are still not signing what that is, that is some structure that is hidden further behind.
So the current laws when we replace hand signatures, it is some easier path, where they say you have a secret code, and there is an administrative chain that holds it together. I think with that administrative chain there is no magic.
You can get a digital signature from VeriSign by calling them and telling them you are Clem McDonald, and they will give you one. So there is a difference between saying I am my bank account and saying I am who I am, because you need someone else to verify you are who you say you are. I think ultimately, the biometrics will be the answer, but we can't mandate that they are going to be in front of every terminal in the near term. Those will have their own set of standards as they are evolving, too.
DR. BLAIR: I basically agree with Clem except for his last observation. That is, I do think bio signatures are going to be a very important part of authentication. However, the other parts of authentication that are very clearly and definitively defined is that you bind the identification of that individual to the document and that the document arrives unaltered and that it is non-reputable. Those are the things where you need digital signatures.
So the impression that I have is that we will wind up using both by authentication because that is an easy quick way to identify the individual, but in addition to that, the other requirements of authentication of the document requires the thing that digital signatures give us. So I think we are going to wind up having a marriage.
DR. MC DONALD: I don't disagree.
DR. COHN: And we're not trying to identify a technology. We are trying to identify a standard.
DR. ZUBELDIA: Whatever they come up with, we need to be able to interoperate with digital signatures across the industry.
DR. BLAIR: My only thought on that is, interoperability is essential, but it seems like we have a list of requirements -- interoperability, non-repudiation, the binding to the document, the identification. It sounds like -- I don't know that we could pick some of those without having the others, if we are talking about electronic signatures.
Correct me if somebody feels that is not correct. That is just my perception.
DR. COHN: Michael, were you going to comment?
DR. FITZMAURICE: I was only going to say that I'm not sure HIPAA -- the law requires all of that. Common sense and building for the future I think does require that.
DR. COHN: I think we are all agreeing at this point. I may be mistaken on this one, but I think I am hearing Kepa saying yes, and let's see what the standards groups can do in terms of coming back with something. I am hearing everyone saying the right words. The question will be, what is there out there that will fit.
DR. FITZMAURICE: I'm not sure we are all saying the same thing, and I don't know what is the right thing. It is just that if one says the goal is to make a signature standard for HIPAA transactions as they are now, it is doable, and something could be done, not in January or June or really in the foreseeable future, because there is enough experience with that part.
But what you really have is two computers, a hospital computer talking with a payor computer. You don't have the individual providers come through those tubes. So it gets tougher when you add all those other requirements.
So I would support Kepa's saying, let's do something that solves the problems of the current transactions, and then change it or add to it as new requirements come up, because if we try to solve all future requirements, I think it will be many, many years.
DR. ZUBELDIA: In my request to the SDOs, I have asked them for a standard on signatures, not for a standard on authentication or how to identify individuals or what constitutes trust. Specifically, a technical standard on signatures. If later on there is a need for a standard way to authenticate individuals or machines or entities or a secure way to develop trust, that is a different story. Let's see if we can have a signature now.
DR. BLAIR: Did I hear you correctly saying you want a technical standard on signatures that would not involve authentication?
DR. ZUBELDIA: No, a standard on signatures maybe with not standard authentication. In some cases, like in the California Medical Association project, you authenticate yourself in one way, and in other cases you authenticate yourself in a different way. But at least if we have interoperability among the signatures, then we can achieve maybe through the PKI bridge that we heard last month, through some different ways we can achieve real authentication. But if we try to solve the whole thing at once, it may never happen.
DR. BLAIR: I agree.
DR. COHN: I see Clem nodding his head yes, I see Jeff nodding his head yes and I see Mike nodding his head. Kathleen Frawley, are you nodding your head?
DR. FRAWLEY: Yes.
DR. COHN: The reason I am asking is because we are asking some other people to do some work, and I want to make sure that fundamentally we are in agreement with what that work is. So I am nodding my head also. I think this sounds like a reasonable step forward, and we have to see what comes out of that meeting.
I guess my own hope on this is that whatever it is, it is extendable, which I think we're all hopeful about.
Is it okay to move on to the next item? The next piece is an update from Clem since Stan Nockman isn't here today, on the claims attachment. What are we going do to?
DR. MC DONALD: I'm going to use a couple of different tools.
DR. COHN: Are you going to use Power Point?
DR. MC DONALD: If that is all right. In the first round there are six inclusive attachments. I say that because they aren't necessarily single things when they say six. These end up being six booklets. These are only proposed. They have not come to any regulatory head at all. They are under discussion in the Department.
Laboratory tests, medications, clinical reports, non-laboratory, which includes discharge summaries, radiology reports, ambulance runs, rehabilitation, ER visits. So these are the six subject contents. Laboratory includes all laboratory reports, so it is a very large attachment area.
I like to distinguish them -- and this is nothing that is formal in any discussion, but there are two styles of attachments. I call this type one. It is send me what you have attachments. So these don't induce labor on the part of the organization. These are parts of the record. Send me whatever radiology reports you have, or send me your discard summaries. So the laboratory attachment is, send me those laboratory tests that you have in a particular context, and I'll tell you about that in a minute.
The same with the clinical reports. Send me those clinical reports that you have, so send me your radiology report or your last chest X-ray report. Medication, there are three different categories, dispensed medications, visit release meds, these are the medications that you are prescribed at release from the hospital or release from a visit, then current meds, which is practically a history issue, what are you currently taking.
The second type -- again, this is my own local invention, this is no formality -- is a fixed form. So you've got to answer these questions, by and large. The best example is the ambulance attachment, which includes questions like, how far did you drive and what is the number of the emergency vehicle.
The rehabilitation plan is a similar kind. It is eight different sets of questions, most of which overlap. These are things are physical therapy, occupational therapy, drug and alcohol abuse rehabilitation, psychiatric rehabilitation.
Then there is the ER visit, which is almost an answer all the questions attachment, but it has got two little pieces with diagnostic studies and clinical findings, which really are, send me what you did.
The way the attachment process works, it is a query and a response. That is not used in any vocabulary, but that is how I think of it. The payor requests information with an X-12 277, and there are two sets of fields that identify the query. One of them is, tell me the subject matter you are interested in. I don't recall how many repeats there are, but there are at least a couple of repeats. That subject matter is identified by a code which can be a class of codes or it can be an individual code. So chemistry tests is a class of codes, and so is serum glucose. They can ask for either or both. They can ask for a list of individual tests or a set of tests.
Then there is also a set of codes which narrows down this search that they call modifier codes, and there are two fields for that. One of them is time limited; it says I want the ones only for the encounter, I want the ones for the month before the encounter, and I can show you that list in just a minute.
The other modifier code says things like, give me the last of those I asked for, give me the first, give me the abnormal ones or give me the worst, that sort of constraint.
So the way the attachment results are delivered, an X-12 275 message is the wrapper. That means that all the HIPAA transactions go through the translators with an immune coverage, that they are safe for the translators. The 275 is a simple message which you can stick a payload into. Then the HL-7 RU, which is the traditional laboratory or Xray, et cetera, delivery mechanism, is the content. The response codes used to identify the panel or battery in an OBR-4, and use link codes to identify the tests.
There are requirements to also send the name you use in your own world, so one would see the names that the local hospital used for that test as well. There is a place in the HL-7 message traditionally for that.
The linked database defines the links between sets and elements. I would like to try to show you -- this isn't part of any standards organization per se, but this is a program that is called ROMA, which will permit users to look at the whole defined structure. This is a little bit in progress. I took it off of the programmer's desk when I came here, and at least once in the airplane it crashed when I tested it. So I am almost certain to make it crash when I do anything at this moment.
But to give you an idea of what these attachments look like as a formally defined -- with all the attributes in this database, such that a deliverer could use this to define what needed to be done. There is a document -- I can pass out a couple of samples. This is the ambulance attachment, which is a simple one, it is like 20 or 30 questions. This is a lot of text and boilerplate in the front.
If we looked at the ambulance claims attachment here, using this tree tool, what you see -- this is the ambulance attachment. The name should be showing here, so this is a tree. It say EMS transport, transport direction, and there is an answer list that is defined by this committee which comes out of the combination of HCFA's form and insurance companies' forms, and they boil down the questions and formalize the names of the answers as tests. EMS rationale for choice of destination, EMS transport, distance transported, EMS transport originating site information.
Some of these open up to three or four questions, composite questions. There is information about the answer list, the values, all the definitional realities should be in this access database which then can be distributed and can be viewed as a tree structure, using a tree tool.
When you pick way of transport, you open it up and it has got three alternative body weights, measured, stated or estimated, and there is a field that says you've got to pick at least one. The cardinality over here says in the case of these -- they specify when they are required, when they are multiple, et cetera. This doesn't quite correspond with the document. In the document you can see the same thing in a little prettier format. The same content is here. It should be fully machinable, so someone could turn this into messages automatically without having to read the document. At least, that is the goal, to have it completely machinable capable and easy to browse. There are differences, but they are all the same general structures, like laboratory, there are a billion laboratory tests, and you send what you have.
The other things that are currently being worked on are, we don't have anything and won't get it in this first round for sure, is durable medical equipment, home health care and end stage renal disease.
DR. COHN: Clem, I think one of the interesting things, and I haven't looked at a recent version of all of this, but I know there was some question about the maintenance issues around these standards. Can you comment about that, or have there been any further thoughts?
DR. MC DONALD: There are issues in discussion. The principal discussion is, do all of them have to go through a full process every time an additional new variable comes out. I think the hope is that that wouldn't be true for the give me what you have standards. So if they come up with a new cardiac component next week, it doesn't have to go through a whole vetting process before someone can ask for that test. Whereas, those ones that say, give me what you have, you've got to fill these all out, like the ambulance attachment.
I don't know where the thinking is right now, but those are the two -- and it is very interesting, the process of narrowing down these piles of charts and sample reports. There was a question on the HCFA one recently that the ambulance driver had to answer that asked whether the patient was admitted. In the discussion process it became obvious that the ambulance driver doesn't know, because the patient is in the ER, and an hour later, 12 hours -- and they took it out, which is even more hopeful about what can happen in the standardization process.
There was a deliberateness -- and then there is a whole series of questions -- there was a time in the process where people just looked at the forms and put everything in as a question. I remember reviewing one and asking, what does CC mean? They went around and around, CC was this thing at the bottom of the form. It wasn't a question at all, but it was just a piece of character on the form. So we got rid of that. After awhile, it became clear that they were adding things that were already in the claim, and they got fairly vigorous about, if it is in the claim you don't have to resend it. In the current ones you did. So this could be a happy thing.
There is a gazillion of these potential claims attachments, if one considers Medicaid issues and all the other issues. So this could be a very large challenge. But I think probably the biggest volume are fairly well identified things. Most of the charts are covered already, clinical reports and lab and medications. There is probably another 20 that are fairly big ones that will get evolved over the next couple of years, God willing and if the process continues.
DR. COHN: Did you need me to show the overheads?
DR. MC DONALD: The overheads were just full details. It is the same as this one.
DR. COHN: Any questions from anyone before we move on then?
DR. ZUBELDIA: Clem, what is going to be the process for new attachments? You mentioned that you hope that there won't need to be a two-year review before something new can come up.
DR. MC DONALD: There are two separate issues. How will attachment issues be managed? The initial hope of many of the parties was that they would simply be external code files, so that there wasn't any special necessity to vet them. There was a lot of discussion about that. I think that there needs to be some vetting, at least for those that aren't, send me what you've got in your chart anyway.
The second part is, what is the process. I can't give you the full details, but the group of six or eight of the standards groups that are involved with the codes, any of the requests for attachment would go to all of them, and all of them could participate in the development of it.
HL-7 is committed to always participating. The process has been today, they do an active recruitment of all interested parties in an area through the HIPAA website and through some other mechanisms, and then have telephone conference calls that go on for months, trying to sort out what the issues are. There is one now for durable medical equipment.
DR. FYFFE: Oh, I know. They go on for months.
DR. MC DONALD: Were you involved?
DR. FYFFE: No, no, no, but so much of HIPAA just goes on for months.
DR. MC DONALD: But in any case, there is a lot of effort put on it, is what I was trying to express. That presumably would still continue. As many of the DSMO groups that want to be active, they can put a sign up and say, I want to be actively involved in it. We expect different attachments to have different interests in different parts of the DSMO. If it does the full vetting, then it has to go to the Secretary and it could be even a longer process.
The challenge is, for those ones that require the providers to fill things out, is that there isn't some -- maybe the DSMO process is enough; some kind of counterforce process one could imagine just drowning practices with big long questionnaires. At least, that would be my worry as a practitioner.
DR. ZUBELDIA: I have another question. What is going to induce providers and payors to use these attachments? If you had asked me that same question three or four years ago, I would have said, it is not one of the standard attachments, you can't ask for it. But I understand that the payors may need other attachments that have nothing to do with the six. That is a back door for the payor to ask a special proprietary attachment, some other ambulance information that is not part of the standard attachment.
DR. BLAIR: Or maybe not the ambulance one, but --
DR. MC DONALD: I think there is considerable concern about that. But as the discussion has gone, they won't be able to ask for a specialized ambulance attachment. It will be the same rule. If you send anything whatsoever as an ambulance attachment, you have to use this one. How do you actually implement it? There still could be potential back doors.
This whole attachment business is scary, because there are two very strong forces pushing at each other. On the one side it says, I don't want any at all. Audit me and put me in jail if I'm bad. The other side seems to want a lot. Each side has low trust in the other side. So that I think is the basic problem.
But it could save people a lot of work in those areas that are standardized, because they wouldn't have to go manually pulling things. I don't know the answer to your question. I am an interested observer to the whole process.
DR. COHN: Thank you very much.
DR. ZUBELDIA: I have a question maybe you can clarify. There has been a lot of turmoil over the ADA charging a fee for use of the CVT codes. What is the plan of the Institute for use of the LOIN codes? Is there going to be a fee?
DR. MC DONALD: To make millions. No, no. Ever since the beginning, there is a copyright notice, and the purpose of that is to keep from having variants. It is free for all uses for any purpose. The only requirement is, if you send the whole database, you have got to send all six of the main fields, and you have to include the copyright notice. But absolutely no -- forever and always, and I think it says eternally in the contract, something strong enough that you can't wiggle out of it.
I like to preach that a little bit. I think we have to have free codes if we want to have a universal standard. Maybe not free, but very, very low cost, and no opportunity to gouge. These will be free, plus the program.
DR. COHN: Thank you very much. I feel I want to apologize publicly to Jeff Blair, since I had given him an hour and 10 minutes on the agenda. I don't think we're going to have an hour and 10 minutes, at least with a quorum from this subcommittee. But I do think that we should walk through what you have prepared, and we should talk about how best to move this forward between now and the next meeting. Does that sound like a good --
DR. BLAIR: You bet you.
DR. COHN: I'm not sure it is a good solution, but to get into the discussion and see where it leads us.
DR. BLAIR: There have been a couple of people that have indicated to me they have to leave at five, so if the group would indulge me, this is a little different. Let's accommodate to the time frame that we have here, so let me do it in a little different style than an open work group discussion here, if I may.
You should each have a copy of the document. It is called a set of working documents. I am just going to step you through in five or 10 minutes as an overview of this. We will then have -- I think there are 15 minutes left, and then we'll have about five minutes of questions to figure out the best way to deal with this afterwards.
Let me give you some feeling for the intent on this. This was the document, it is called a set of working documents. It is to help us start to discuss these things. These are not drafts per se. These are not a set of proposals. I have referred to them as a set of ideas, they are reference documents, they are taking a path and seeing where it leads us, to see what some of the issues are. So I am going to just step you through real fast.
The first item in there, which is your second page, is the work plan. We saw that work plan in, I believe it was our September meeting. There was the suggestion that we change two things. Number one, we shorten the time frame for our data collection. That was cut in half from four months to two months, and then the other thing is, Simon suggested that we add in an indictor in the work plan for outside feedback, and I think is stuck in there from March through April or May or something like that.
Those are the two elements on that. If you go to the next page, other than that, it is the same as we saw in September. This is an ongoing thing, whether it is either a living or unfinished document.
The next page, Clem contributed a number of very excellent ideas that I think can help us a lot. I did review them by phone with Simon. We agreed with almost all of them. I included Clem's words almost verbatim on most of his suggestions. What I did, because of the process we are going through, you won't see the examples that Clem might have had in his mind or references to a specific SDO or terminology, so it is in a generic format, but when we come back to this, or if we look at it during the next several weeks by e-mail, what I would have you do is probably comment on those things you feel comfortable with or things that you don't. But I think this is an excellent starting point, and it probably summarizes a lot of the basic feelings that a lot of us have, and we could modify it from there.
The next page is -- if I recall correctly, the beginning of, what kind of a process we would use to come up with criteria for the selection of standards. I thought we really have to start with the guiding principles for the selection of standards. If you look at -- there are two pages in there of guiding principles for the selection of standards.
When I looked through those, I found that many of them are very helpful as discriminators that could help us in the selection of standards. However, there were several in there which really didn't appear to be functionality, which is a characteristic or attribute of a standard. They seemed to be more appropriate for the software in an information system.
There were other things that were so basic and fundamental that I thought of them more as, if a candidate doesn't have these basic things, then they are not even a viable candidate. So I titled those as basic screening. You can go through and comment, see if you agree with them, see if you don't.
The next slide in there is just one slide to say, those are the two that just seem to be so basic that I just labelled them as screening. But going through this process and stepping it through this way was a way also to try to drill down and narrow the discriminators that we would use to select the standard. So after you take out the software ones and after you take out the ones that might be for screening, you are left with eight instead of 15 from the guiding principles, which might be useful to us in a process for selecting standards.
I took a look at those in terms of -- and I may be out of order slightly on my pages, but if you go to the one where it does list the discriminators, either eight or nine, what I did on that is, I noticed that almost all of them are good discriminators for both message format standards and for terminologies, but there was one that was clearly relevant to medical terminologies, that wasn't thought of in terms of message format standards. But again, look through those, see if you see logical flaws or a different way we could approach this.
In any event, if this approach does make sense for us, if we do feel like we want to use an approach like this and modify it or something like that, then I thought I would just take it to the other level to see what kind of problems or issues we would face.
So if you go to the next page, which is page 10, I wind up saying, okay, if these are discriminators, then what kind of rating scale can you pick. I wound up -- this was my first shot at it, and I just did a test; these would be the characteristics for each of those eight discriminators. There may be better ways to do this, but I just wanted to see if I could consistently come up with something where we could say zero to three, which is four different pieces.
Anyway, then I wound up taking it one more step. Clem's thought, which I agree with and I think Simon agreed with, is that market acceptance really should receive a great deal of weight. But now I was in a situation after going through this process, where I realized, these other factors can't be ignored totally, they play a role, too. So I just gave a shot at putting down weighting factors, some for medical terminologies that I thought might work, some for -- on the medical terminologies, clinical specificity seemed high, of course market acceptance was high.
Anyway, you can see where that was leading us, and you can give our critiques on that.
The next piece is -- and this by the way could wait. This doesn't have to be quick, but you can wind up seeing our thinking patterns and some of the resources we have. The next piece is, back a couple of years ago, this was under the auspices of ANSE health care informatics standards board, we created an inventory of clinical information standards.
Kepa, you were not here at the time.
DR. ZUBELDIA: No, I wasn't, but I was in the HISB meeting when this was presented by someone.
DR. BLAIR: I brought a copy of the book only so that you could see the quality of the data that the SDOs gave to us. This is much, much more -- Clem, I am agreeing with you -- this is much more than we want to get into. However, there is value in glancing at this, I believe. That is why the questionnaires are in there, because I think that it may be easier for us -- and even those questionnaires don't necessarily match up to the age discriminators that I have there, so they would have to be changed.
But we had spent months in coming up with those questionnaires. When you wind up doing that, you wind up getting challenges, and there are things in there. I thought that it might be useful to pare that down rather than start brand new with a brand new questionnaire or do a little bit of both or something like that.
So anyway, it is in there as a reference. It is not a draft of what we should do. It is far more detailed and complex than I hope we have to deal with, but it is there.
Michael Fitzmaurice, are you still here?
DR. FITZMAURICE: Yes, I am, Jeff.
DR. BLAIR: I know you have to leave at five, so could I turn it over to you for your comments so that you can get your comments and observations in before you have to leave?
DR. FITZMAURICE: Sure. As I went through it in a little bit of detail, I am starting with the first page of PMRI standards, as I read through it and got down to the fourth box, March to May 2001, it talks about solicit public comment on revised criteria for selection, PMRI standards.
At this point I hadn't gotten to the back, so I didn't know what those revised criteria were. It looked like they were the same as the list of desirable attributes, the guiding principles. I have a note, when do we get the revised criteria, when should we ask for public comment. This looks like March through May 2001, so that question is answered, and how; do we have public hearings, do we send out -- maybe publish a notice saying we would like to have your original comments come in. That is a question to be resolved.
DR. BLAIR: You can see the path here of drilling down to maybe eight discriminators. The other piece is the work plan. We didn't indicate that we would work on that probably during the next several months and then probably have outside hearings to critique whether we are on the right track.
DR. FITZMAURICE: I got smarter as I went along. Down at the bottom, review the recommendations for PMRI standards and prepare to present these recommendations to the Secretary. I think we had a conversation about this, Jeff. My thinking was, what does the Secretary do, because HIPAA doesn't say mandate PMRI standards. I would think at the very least, if the Secretary finds favor with it, the Secretary might say, receive them and then put out a press release saying, I have accepted what NCVHS has given me, it looks good to me, and I am going to recommend that my agencies follow them in their movement of patient medical record information. Or maybe even less than that, I am going to have somebody study it, to find out where it would be most fruitful within the Department.
At the other end, it could be the Secretary making recommendations, these are so that not only will I ask my agencies to follow them, I am asking the private sector to adopt them and to give me some feedback.
So there are all kinds of options within here. We will have some discussion on it, but I wanted to lay out my thinking in the beginning, so that as we go along, we can see what actions might be advisable to the Secretary. Or maybe don't give any recommendation for action, let the Secretary decide what he or she wants to do.
DR. BLAIR: Within the spectrum you have just described to us, are NPRMS within that spectrum as well?
DR. FITZMAURICE: No, they are not in that spectrum, because at this point it would not be regulatory. You can tell directly the operating agencies to do something, and you probably don't have the power to tell the private sector what to do. So I don't have in here an NPRM process in my thinking.
Moving on to the next page, some areas of focus, --
DR. MC DONALD: Mike, I think that is very important. If that is the case, and that would be my bet also, we ought to make that announced ahead of time, because it will reduce the heat in a lot of this discussion, if it doesn't look like it is going to be an absolute thing, an encouraged thing. I think we ought to know that.
DR. COHN: I think that there is something for us to mull about. Once again, we don't know what the temperament of the next Secretary is, but there is within the HIPAA regs a piece that I referenced earlier in the legislation, that talks about other standards of administrative simplification.
Now, I would certainly not say that all of these could be NRPMS, but one for example could make a case that message format standards for AVP is certainly pretty administrative. So some of these things might find their way in. A lot of them might not, but there might be some that are actually appropriate as saying, this is something where administrative simplification makes sense to be on the standard.
So I am not sure we would say at the get-go that nothing could be done that way. Is that okay with you?
DR. MC DONALD: It is all okay. It is just interesting, if we knew the scope of what could come out of this and it was narrower or broader, it might influence how we process it.
DR. BLAIR: I think what Michael was saying though is that we may not be able to make that determination until after we have gone through this first 18-month process, and we see our level of confidence in what we are recommending, and we could wind up also getting some industry feedback as to the support for this.
Then the third part of that decision is probably going to be the inclination of the Secretary as to how proactive he or she wants to be, is that correct, Michael?
DR. FITZMAURICE: That is correct. I wouldn't want to put these in the same category as the mandated administrative standards, because industry has not had a chance to vet it among itselves and say yes, we would like to adopt these uniformly and nationally. I would want the Secretary to have an opportunity to seek and have that kind of buy-in.
DR. BLAIR: So Clem, you may have your pie and eat it too, because if we are going through this process, and a number of this don't feel entirely comfortable and strong about what we are doing, then we may wind up recommending that the action be advisory instead of regulatory.
DR. MC DONALD: I don't know what my pie is or what I want to eat. But my most thing is, I don't see why we have to spend 18 months on this. If we think about doing it in stages, the law says it has got to be an ANSE SDO. There are only six of them or something like that, or seven. It is not like we are going to hunt around throughout the city for days and days, figuring out what they might be. So I think you could boil down fairly fast in some of these easier areas.
What I said is, I thought vocabulary wasn't an easy area. I would argue not to try to do vocabulary in our first phase, but do a lot of thinking about it. There are certain things that could fall out in that time frame that make it easier.
DR. FITZMAURICE: Let's hold that and let me move on. Some ideas for PMRI focus. First decisions made in stages, sure, stages are fine vehicles. I was suggesting in the first step, consider only standards with wide industry acceptance and use. Self preservation works wonders, yes.
Thirdly, specify the standards by parts. I guess so. I can't disagree with the logic of it, but if a standard developing organization proposes the standard, we want to work with the standards organization to see is it acceptable to do it by parts.
DR. MC DONALD: For HL-7 where I am familiar, that there are parts of it where you wouldn't claim them right now, they are early and green, and there are parts that are older and solid and being used.
DR. FITZMAURICE: I think of HL-7 as one standard.
DR. MC DONALD: I think all of them have that set of packages, and they have different levels of use.
DR. BLAIR: Since I took the examples out, it wasn't clear that what Clem's thinking was is that you may have order entry and results reporting, but you are not necessarily going to have home health care, which never was able to get to an implementable standard within HL-7.
DR. MC DONALD: I can buy those even as separate standards. It is a matter of semantics.
DR. BLAIR: Okay, but that is what he was intending with that.
DR. FITZMAURICE: Number four, agree. Should follow the same approach as we used in administrative standards, to a large degree, agree. Skip six. Seven, I noticed that all of these seem to be HL-7 standards, but there is a reason for that.
DR. MC DONALD: No, they're not.
DR. FITZMAURICE: They're not?
DR. MC DONALD: No.
DR. FITZMAURICE: Message format standards for admission, ADT for order entry.
DR. BLAIR: Could I raise the level here, because I feel as if one of the important things in this process -- patient medical record information may be even more difficult for the industry to accept and digest than financial administrative ones. We look at all the difficulties people are having with that. I think we really have to make sure that this is a careful process and not going down preconceived notions.
I am saying that, even though I very much agree with you, Clem, that doing the low-hanging fruit and doing things with market acceptance is right, but I think we need to think in terms of the generic areas, because there may be some other generic areas we want to look at.
So I am trying to stay away from a specific reference to a standard at this point. Clearly it is going to lead us to that in many areas, but I think that is the right thing to do.
DR. MC DONALD: And my defense is, I didn't really recommend this many. I think there were three named standards --
DR. FITZMAURICE: No, I've got nothing against HL-7 standards. I just wanted to enunciate that.
DR. BLAIR: And I did add at the bottom in the other category that we might look at some other areas. But again, the market acceptance is a key piece, so even if we start looking at other generic areas, whatever standards there are in those generic areas --
DR. FITZMAURICE: On three and four which deal with privacy and least personally identifiable form of information, I have got written, lead to the privacy rule. I think that will be taken care of apart from the PMRI standards. I wouldn't make that part of the PMRI standards criteria.
Number 10, are precise and ambiguous but as simple as possible. I think we all want that, but we don't know how to do it. I refer to Gary Dickenson. If Gary Dickenson says this is ambiguous or this is precise or simple, I go with him.
Moving to the next page, draft matrix for applicability and utility, down under balancing, precision and simplicity, and one can also add ambiguity. We don't know how to measure utility or applicability. We could run some tests and see what is the number of FTEs required for coding this. If one group has fewer FTEs per code, then maybe it is simpler. Not a very strong comment.
Those are all the comments that I have. I really appreciate the strong effort to get us right into the criteria for selection, and the fact that Jeff worked with Clem to come up with particular standards as candidates I think is a strong foot forward. I think that is probably where our focus ought to be, to apply the criteria, agreement on the criteria, and then try to apply the criteria to some of these standards. I think we can shorten the time down. We do want to be deliberative, we do want to get industry feedback. I don't know that it is going to take 18 months, but I think we have a way to start.
That is where I am going to have to leave.
DR. BLAIR: is there anyone else that has to leave within the next five or 10 minutes?
DR. COHN: No. We have already lost a couple. Would the preference of the group be to discuss this, or do we want to discuss about how to provide input? Do others have things they specifically want to comment on? Kathleen?
DR. FRAWLEY: Yes. This is a very well done work plan in terms of moving us forward. But the one thing I am concerned about in this area of work is that there are specific requirements for patient medical record information that are not standards. So it would go back to state statutes and regulations, the Medicare conditions of participation, the Commission on Accredited Health Care Organizations requirements for a medical record. You have CARFA that accredits rehab facilities, you have different groups. While those would not be considered per se standards, those are the requirements that health care organizations are licensed and accredited under.
So I just mention that. I don't know how to blend that into this work effort, but I think that there needs to be some way to bring that forward.
DR. BLAIR: Is that something where you could summarize that in an e-mail to our subcommittee, so that we could all look at them and see what we can do to recognize --
DR. FRAWLEY: Sure.
DR. MC DONALD: Could you re-read that phrase or paragraph in the law, Simon? I think we are charged to deal with the transmission of health information, which still includes some of those activities, but it wouldn't be quite as large. I think it is a good idea to be thinking of those other ideas. I just want to be sure we are focused on what the law says we are supposed to be doing with this.
DR. COHN: I don't have it in front of me. It is standards for electronic exchange.
DR. MC DONALD: There was something about transmission of or something.
DR. BLAIR: Could I ask the group in general, while we are still here together, if you have any thoughts about dropping this down to a reduced number of discriminators, instead of doing with all 15 of the guiding principles? Do you at least feel somewhat comfortable with driving it down to the eight discriminators? Yes, no?
DR. MC DONALD: At least. At least that little. I think you might even go further.
DR. BLAIR: Okay. Then the next thing that I guess I would like a little bit of reaction to is, if we have those eight, how do you feel about the slide -- and I am not saying those exact weighting factors, but just the idea of something like that with the weighting factors that are there? Do you feel like that is getting close to what we need to do, or is that in the wrong direction?
DR. COHN: Not having looked at it before today, I'm just wondering, is that a critical issue, that we need to decide the weighting factors?
DR. BLAIR: I don't know if there is a pick on them. I just wanted to know --
DR. MC DONALD: Firstly, I think as a set of weighting factors, it ain't that. It reflects what you emphasize, except there are some that are the ANSE part. It can't be a huge percent, but on the other hand, you can't pick one in a domain that isn't ANSE. So it is like an external thing that is going to be an overdrive control.
DR. COHN: Actually, Clem, that is not technically true.
DR. MC DONALD: You can't pick one in a domain for which there is an ANSE standard unless there is an ANSE standard.
DR. COHN: No, that is not actually technically true. If the Secretary determines that for whatever reason there is something that is not an ANSE standard, that has so much greater value to the health care community, the Secretary is authorized to make an exception there. But the preference is for an ANSE standard.
DR. BLAIR: Yes, the burden is high on the Secretary.
DR. MC DONALD: I read that differently. I read it that it says they may select other standards, but it starts out to say they must first choose ANSE approved SDOs. They can also -- other standards that are not covered.
DR. COHN: We can go back, that is something --
DR. BLAIR: But the Secretary can adopt a different standard if there is no ANSE standard, but number two, if there are some justifications as to why it would be a better standard.
Simon, you were going to open up the discussion to how we should proceed to critique and comment.
DR. COHN: Yes. First of all, I feel badly because I expected that we would have an hour and 10 minutes, but I think that first of all, we need to devote some time that is blocked off in January. Jeff, I am sensing from your time frames that you are proposing a focused hearing in March or a little bit after.
DR. BLAIR: Can I back up here, see if this makes sense. What if we invite serious critiques and comments by e-mail before the end of this year and then in our February meeting we lay out -- can we spare two hours to go through this? By that time we will have the comments and the critiques, and wind up pulling that into our first drafts on this, and we go through those first drafts, and it may take a couple of hours to do that. Would that work?
DR. COHN: Certainly. People may not be able to leave at 1 o'clock on the second day, but we'll certainly have them out by three or so. Yes, I think we can commit to that. The time frames you have envisioned look to me that it supports that.
DR. BLAIR: If we could do that, I think we would be all right. Clem, I am turning to you on this, because --
DR. MC DONALD: I don't want to push it any further than I have tried to already. I would still love to see three straw proposals and then get to the real issues, because there will be a lot of issues.
DR. COHN: To meet the real issues are which areas that we need standards on. Maybe I'm wrong about that one.
DR. MC DONALD: You can say we need standards, but we can't just declare we want a standard. We have to relate to what is out there.
DR. COHN: I agree, but isn't that the areas that we're going to say that these are areas that we are going to request submissions on?
DR. MC DONALD: We can play with the coefficients, we can make it come out any way we want by being formal, by saying, what does the world object to, what will happen when we say we are thinking about either this pattern or this pattern, and what is going to scream out of the walls, and how do we deal with those issues that come out that we hadn't thought about.
There just aren't billions of choices. The first thing I would say is, I think we can do something in six to eight months. The first thing we would say is, we would stall on vocabularies, and I say that for a number of political reasons. There are certain vocabularies that if we get embroiled in, we will never get anything settled. It will be a long time before we get any conclusion.
Secondly, there are negotiations that are currently going on within NLM about -- if it comes out one way, it would be much easier to do something than if it comes out another way.
The third thing is, there are activities going on in the drug coding in both NDC and some other areas, but right now things are unsettled. We have stalled that, but we did hearings to gather data on that. There are the issues of security and privacy, it seems like we could just --
DR. BLAIR: My inclination was to leave security out of here, because I think Kepa's group is concentrating on security.
DR. MC DONALD: There is a very narrow one we are talking about, but there are other issues. I would absolutely not say take all of one group's standards, including the ones I am in favor of. I think you've got to say, let's take the smallest subset that is very, very accepted, and do that. If we can get that through, then we can wrestle with the tougher ones, and we will have some momentum.
DR. BLAIR: Clem, I think there is really a very great degree of agreement with the things you have just said. I think the only difference is that we are trying to create a balance. The balance is that I think a lot of us are sensitive to the fact that these are areas where there has got to be out in the health care community confidence that we want through this process in a very open, very fair, very deliberative process, and we can defend out -- so just taking a little bit of time up front.
DR. MC DONALD: I accept where you're going. But what we did with X-12, we said this is where we're going, and we took hearings. We didn't do it this way, and it worked fine. So I don't know that we need to bend over backwards like we don't know anything and we don't think there is any directions to go.
But I'll accept this process. I just want to keep pushing it to make it as sharp as we can.
DR. COHN: And I think we can mull over the activities and time frame and the work plan. In January when we look at this, we may say, this stuff is pretty obvious, let's have some public hearings in March or April, if people think these are okay --
DR. MC DONALD: If people accept the idea, we'll do it in steps, we'll do another step and take the harder stuff.
DR. COHN: Yes, I don't think there is any intent to solve all the problems at this point. I will say that we all have to be aware of that we have got lots of things on the subcommittee agenda, so it is a question of balancing them all. But I certainly think we can devote some time in January to getting into this. We can devote some time either in March or April to a focused day and a half on these, hopefully getting the public and other input that we need. We may discover after that, that that is not bad. That will probably take us until October to get the full committee and get a letter out to the Secretary, so instead of 18 months we'll have done it in 14. It is amazing how quick still is a year.
DR. ZUBELDIA: Jeff, how do you propose to solicit the comment on this?
DR. BLAIR: You mean during the next few weeks?
DR. ZUBELDIA: Yes.
DR. BLAIR: Please, just e-mail me with your thoughts. I sent you all the document in electronic form. If you want to do a tracking changes if that is easier for you to do it that way, make comments on the document, you can do it that way.
DR. ZUBELDIA: I am thinking about comments from the public. Are you interested in comments from the public?
DR. BLAIR: Aside from setting it up to do it, let's see where we need concern, where we need feedback, where we are in February, in that February meeting. I don't have an idea at this stage as to how to do that yet. Is that all right?
DR. COHN: Yes. I am presuming that there should be a process after February, especially around the areas of focus, that get vetted from the other feedback publicly as well as what would be the right standards for that. That is the public process. There may be some areas that we haven't appreciated as low hanging fruit. Kepa, other comments or questions?
DR. ZUBELDIA: I was thinking about that March through May solicit public comments.
DR. BLAIR: Isn't that in the work plan, the March through May? That is when I thought we would be ready for that.
DR. MC DONALD: Comments on this approach or comments on the answers?
DR. BLAIR: I think it is going to be on the approach.
DR. MC DONALD: We could spend 10 years on this.
DR. BLAIR: But the thing is --
DR. MC DONALD: You mean we're just going to argue about what weight we put on there?
DR. BLAIR: But think about this, Clem. If we don't have a hearing --
DR. MC DONALD: No, I'm saying have a hearing, but are you going to have a hearing about the process of developing the process?
DR. BLAIR: It is going to be a hearing on, do we have the right criteria for selection, are we focusing on the right areas, and we wind up getting some degree of industry feedback, yes, we are going about it the right way. Then the next thing we wind up doing is saying, yes, we've got industry feedback that says, yes, we are heading in the right path, we have the right criteria for selection. Then we can go forward and wind up exercising that.
DR. ZUBELDIA: Jeff, maybe we don't need to have a hearing on that. Maybe we can solicit comments through the website, on the Internet, post it, and let people comment to a specific e-mail address and get some feedback that way.
DR. BLAIR: That is possible, too. Simon, how would you feel about that?
DR. COHN: I think the things that could move the process along -- I think we do need some verbal public comment, but the question is whether or not we could get some comments from e-mail or from experts, whether or not we do a set of hearings that somehow collapsed some of this all together. We do want agreement from the industry that we are doing the right process. We also want to know if it is the right focus and yes, if it is the right focus, what do you think are the right candidates for these standards, and whether or not that has to be held out into multiple hearings, making people come out multiple times to Washington to testify, or whether we can somehow consolidate that into a full two days at our discretion.
I hear Clem speaking to putting it all together.
DR. MC DONALD: I'm just Type A. I can't help it.
DR. COHN: But Jeff, I presume you would be willing to be flexible in your work plan?
DR. BLAIR: Oh, sure.
DR. COHN: If we feel comfortable that February that we want to go forward that way.
DR. BLAIR: Yes.
DR. COHN: I have one or two other items for just quick discussion or comment. Number one is that Jim Scanlon and I are going to be working on the next Congressional report on HIPAA, which I suspect you will all be seeing in some sort of a draft form prior to the February meeting. Both Jim and I are looking at each other, wondering how we are going to get it done, but I think it will have to come here in a draft format for review, for your input, go into the full committee for at least their first review at the end of February. Any thoughts that any of you might have -- the fact that the first rule has been published; maybe we will have privacy if we are lucky by February 1. Those are the two keystones referencing things around the WITI-SNIP. Our letter to the Secretary about mitigating issues and all of this. These are the flavor that I would take. Also we can comment about the PMRI standards. So that would be a separate report to the Secretary.
DR. SCANLON: That wasn't really part of the HIPAA data standards.
PARTICIPANT: (Comments off mike.)
DR. COHN: It is more of a reminder. Let me think about that one.
DR. SCANLON: Part of it is simply updating on the actual implementation, what are the processes with the various NPRMs and final rules. Then the issues that are emerging are already in the activities of the committee in terms of anticipating the --
DR. COHN: And the PRMI thing probably does need to be referenced, because it is a slightly different audience. The PMRI is with the Secretary, whereas this one goes to Congress.
PARTICIPANT: (Comments off mike.)
DR. SCANLON: We can't hear you. Can you get to a microphone?
DR. COHN: The issue is the PMRI standards. I think the recommendations were directed specifically at the Secretary, whereas the HIPAA yearly update for the Congress goes to Congress and the Secretary, so it would be additional information that probably Congress hasn't had.
DR. BLAIR: I think Simon was asking for suggestions or thoughts on that, as the two of you wind up crafting that report to the Congress. I'll preface my comments by asking first, is this an opportunity for us to garner support from Congress for moving forward with health care informatics standards? Because if it is, then I have a couple of suggestions.
DR. SCANLON: We will know more as we get a little closer. A report to Congress usually is not -- you don't gain much, nor do you get additional support necessarily with a report to Congress. It depends on a lot of other factors, perhaps the way we phrase things or the way we characterize things, who we brief. But I think we will know a little more when a couple of months transpire.
But maybe we should ask everyone on this subcommittee to look at the current report and give us some ideas, about, is the basic structure all right, is the outline all right. In addition to the factual update, where things stand, are those the same kinds of themes we want to raise, are there other themes we would want to include.
DR. BLAIR: Will the report somehow mention that because HHS did not have additional funding for -- or that it has come to our attention, now that HIPAA is in the process of being implemented, that there is need for additional support and the funding is not there within HHS to provide that additional assistance. Everybody is doing the best they can to try to deal with that, but that is a constraint.
DR. SCANLON: You have to be careful when you are talking about resources.
DR. COHN: That may be fine. That was the theme in the last report, though. So I would agree with you completely, Jeff. That was already in there, in a letter or -- and there was a cover letter to the Secretary pointing that out.
DR. BLAIR: So we have had another opportunity to say that.
DR. COHN: Yes, but I think it may well be appropriate again. So Jeff, you're saying you like the theme from last year.
DR. SCANLON: But there may be others too, Jeff.
DR. COHN: A lot has happened this year.
PARTICIPANT: (Comments off mike.)
DR. COHN: Here we go.
DR. GREENBERG: I was saying, compared to the previous year, I think you just ran down, Simon, the different things to report on. There is quite a bit to report on this year which might make the outline a little different, and the fact that you have the hearings with early implementers and all that.
DR. BLAIR: There is one piece that I'm not sure exactly that we might have said. Some things we heard today for example, where even those folks that are struggling to move forward and aren't sure that they are going to meet the deadline -- I can't say all of them, but there does seem to be broad acceptance of the fact that ultimately this will wind up saving our health care delivery system a great deal of resources.
So people see that there is a tremendous benefit at the other end, but they are struggling now, and if there are not resources to help them through this implementation stage, they are going to ask for delays.
DR. SCANLON: I would say any issue that is seen to a potential barrier to implementation is probably grist for the mill, at least for the draft. I would be careful about who exactly is the beneficiary of the resources. Normally we don't pay people to obey the law if it is required.
I think the issues of resource limitations is going to raise a potential barrier to speedy implementation. But it will depend on the wording of the issue specifically.
DR. COHN: Other thoughts by e-mail or otherwise will be appreciated. Just be aware that this is going to be coming up.
Be aware also that the issue of code sets again came up at the executive subcommittee meeting. We were asked -- which we are not going to do today, but I will try to bring something in for February about a work plan around code sets for 2001 in the area.
In February we're going to be talking about NDC some, because I know the NUBC is bringing forward an issue around the NDC codes and all of that. At this point we have it as an issue item, we know about it. Kathleen was going to lead up that area, but as you all know, Kathleen is going to be leaving our subcommittee after today.
DR. FRAWLEY: But my offer still stands to help in terms of that process. So I would be more than happy to work with you on that, in terms of fleshing out a plan and some of the issues that the subcommittee may want to address. Whatever I can do on that, certainly I'd be happy to.
DR. COHN: Thank you. I do bring it up as another thing that got dropped in our lap again.
DR. MC DONALD: Simon, this came up in an attachment to the NDC thing, too. No one seems to know what the current reg is. It is currently saying you've got to use NDC, but for what? The billing transactions? Some of these medication things, the person stating it doesn't know what the NDC code of the drug is, or even prescribed. When you prescribe it, you don't know what NDC will get given.
So if the current reg is very narrow, we are okay, but if it is broad as some think, it is tough in attachments.
DR. SCANLON: It is in the final rules. We'll have it here tomorrow. Karen Trudel will be here as well.
DR. COHN: We can go into it further around the NDC stuff, but it is an issue that was coming up. They asked us if we would hear from them and try to put together a balanced panel on that.
DR. GREENBERG: That would be at the early February meeting?
DR. COHN: Exactly. We still as you know have the hearing dates scheduled right now for February 1 and 2. I have held off scheduling the March, April and May dates only because we are waiting for the membership change. The question will be to find out if any of the new members are going to become members of the subcommittee, and if so, then try to --
DR. MC DONALD: I bet one will.
DR. COHN: One I am hoping will, anyway. But in that case, we should query him for the March, April and May dates also.
DR. GREENBERG: I should probably give him a call, because he wasn't able to come to this meeting.
DR. COHN: Beyond that, let me just make a final comment about February 1 and 2, based on what the agenda is likely going to look like. I would certainly anticipate that we will be adjourning probably around 3 o'clock on the second day. I may be off on this one, we may get out a little bit earlier, but I would not try to make a 3 o'clock flight, just to warn everybody about that.
DR. BLAIR: Let me hear that again. We should not try to make a 3 o'clock flight on the second day?
DR. GREENBERG: Right, and definitely not on the first day.
DR. COHN: Right. We will know better as it gets a little closer, but I am just warning people in advance, with all the various things we have going, with the digital signature and the discussion of PMRI plus discussions on the NDC issues, and from the DSMOs and WITI groups and others, it seems like it is going to be a pretty full agenda.
I want to again acknowledge Kathleen Frawley. She has been a wonderful member. We really appreciate your participation. We know you will still be around. But we do thank you for your great participation and help over the last couple of years. We will miss your sitting around the table here.
Any other business or any other concerns, thoughts? Okay, we stand adjourned.
(Whereupon, the meeting adjourned at 5:40 p.m.)