[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS AND SECURITY

November 16, 2001

Hubert H. Humphrey Building
330 C Street, S.W.
Washington, D.C.

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

PARTICIPANT LIST:

Subcommittee Members


TABLE OF CONTENTS


P R O C E E D I N G S (8:40 a.m.)

Agenda Item: Welcome and Introduction

DR. COHN: We have about an hour and five to ten minutes for the subcommittee meeting. This is the Subcommittee on Standards and Security of the NCVHS. We will quickly go around and do introductions and then we get into the body of the discussion, which is planning for the December subcommittee hearings and talking a little bit I guess, just very briefly, about what is going to be happening for the first half of 2002, which should take us about two minutes, since most of you have already been involved in the planning.

With that I am Simon Cohn, a member of the committee and Chairman of the subcommittee.

MR. BLAIR: I'm Jeff Blair. I am Vice Chair of the subcommittee and I am Vice President of the Medical Records Institute.

DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, a member of the committee and subcommittee.

MR. SCANLON: I'm Jim Scanlon with the HHS Office of Planning and Evaluation.

MS. HORLICK: (Comments off mic)

DR. KOLODNER: Ralph Kolodner, staff to the committee and Department of Veterans Affairs.

MS. BEBEE: Suzie Bebee. I'm staff to the subcommittee and with NCHS.

MS. TRUDEL: Karen Trudel from the Center for Medicare and Medicaid Services, staff to the subcommittee.

PARTICIPANT: (Comments off mic) - with NCHS.

MR. WINE: I'm Mark Wine, Department of Veterans Affairs.

MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics.

MS. GILDWAY: Lee Gildway -.

Agenda Item: Overview of Planned Hearings and Issues for the Remainder of the 1st Half of 2002

DR. COHN: Okay, and just to briefly review what we are going to be doing, I mean our plans for subcommittee hearings and issues over the next six months, just to make sure everybody is on track. December 13th and 14th are our next hearings, which will really be what we are focusing on today, making sure we are all set for those. The first day will be PMRI standards discussion and steps. The second day will be HIPAA implementation status, and I think we will spend a fair amount of time talking about what it is we want to see happen for that session, so Karen can help us plan that one out.

Now in February, I guess I should ask Kepa, I've asked you two or three times about email. I think you said yes, but I've never been quite sure. February 6th and 7th we will be meeting?

DR. ZUBELDIA: Yes.

DR. COHN: So yes, okay, February 6th and 7th will be hearings focused on issues related to procedure codes. Now at least from my view this includes going back and querying people who were asking for code sets, procedure code sets that handle areas that were not felt to be covered so far, heretofore the administrative - transactions, and sort of finding out how they are doing it, what they need, et cetera.

This will probably also include issues around implementation, of how HICPIC and CPT and everybody else sort of is, you know, releasing these things, and what sort of updating and, you know, are there issues that are perceived by the public around that, you know, - help us all if CPT is putting things out on a quarterly basis but CMS and HICPIC is doing things April and October, and you know, so every month there is an update of some kind or other.

There is also I think, looking back on local codes, and HICPIC 2 - recommendations to see really where we are with all of that, and other issues that come before the group. And I've actually asked the previous co-group, which was Betsy Humphrey's, Donna Picket and I guess Pat Brooks, to assist Kepa in terms of organizing this.

You all have to realize you and I will be talking. I've pretty much got to recuse myself from any voting, because I'm so conflicted in this area (laughter). I'm such an expert that I can't say anything about it. But I think that this one should be a timely and important hearing, because I think all of the groups are really gearing up and will have HICPIC 2002 at that point, so we will see how far they have gotten incorporating the level 3 codes, et cetera.

And Kepa I see you have publically nodded your head and said yes, so I will not send you any more emails asking you if you are going to be chairing that.

MS. TRUDEL: Can I raise some other issues that we need to, I've been kind of tracking this off to the side. There were discussions last summer about the committee going back to look at how the various code set maintainers were carrying out their processes to make sure that they were open and to make sure that they were responsive, and I know that there was some special concern about the CB2 - terminology, and I know I keep getting calls from the dental folks reminding me that, you know, this is something that we said we were going to do.

There is also a SNIP group under WHTE that is pulling together a white paper that shows how each of the code set maintainers does their job. So if we do an overview of that process, we could possibly get somebody from that group to come in and just present their paper and that would get a lot of our work out of the way. Good intro.

DR. COHN: Great, thank you. Why don't you note that and we can send an email off to Betsy or whatever so she has that on her radar.

DR. ZUBELDIA: And we'll be talking about alternative codes, HISC and so on.

DR. COHN: Yes, exactly. I think that would be the sense of it. I think they are willing to help, and as I said, I mean Karen sounds like they are willing to help also. As usual, trying to get these hearings together involves not just a good idea, but we need to get the staff support in putting it together. But exactly I mean that is easier than going back and looking at some of those and seeing where we are, as well as what the need is, and we have all certainly received enough emails to know that at least there is some perception that there is an ongoing need for some of these.

DR. ZUBELDIA: And we also need to talk about codes for vision.

MS. TRUDEL: Vision? Okay.

DR. COHN: Ocular.

DR. ZUBELDIA: Yes, well lenses, glasses, they have a real coding problem.

DR. COHN: Now I will tell you, at least from my view, that this is probably a big enough area that you need to be careful about what you put into a day and a half, and these may be things that we do also further down the year. I just want to warn you, this is one of those, at least from my experience, once you start digging into it it is sort of like hard to know what, there is no bottom. So just a warning on that one.

MS. TRUDEL: Well perhaps what the first hearing would do then is to sort of triage what the issues are.

DR. COHN: That may be useful, okay, that would be good. I mean and sort of it may be appropriate for lenses, I mean you will decide that.

DR. ZUBELDIA: The department, they say they can't bill with the claim because they don't have codes.

DR. COHN: Oh, well that's certainly a legitimate issue along with others.

MR. BLAIR: Our motive pretty transparent when it comes to ocular codes (laughter).

DR. COHN: Anyway, that's February. On April 9th and 10th, tentatively the topic will be diagnosis codes, and that is probably our first occasion to look at issues around ICD 10 CM and hear from the industry and others about sort of what is it going to take to be implemented, they want to see it implemented, should be a, I mean I, this is obviously at the request of the NCHS, who is I think looking towards implementation at some point. Helene?

MS. JORDAN: When will that be again, I'm sorry.

DR. COHN: April 9th and 10th. As I say this, we will reflect on something after we are done with these dates, but that is I think the intent at this point, knowing some of these dates could be switched around depending on department and committee needs.

Now final dates we have scheduled are May 29th and 30th, and topics right now on that are open, knowing it is very easy to fill an open schedule at this point. Now as we sort of looked at things I think the question will be, as we know, there's lots of things on our "to do" list, and I really don't think I want to go through them right now, but certainly we need to be responsive when the enforcement and compliance issues begin to start coming forward.

DR. ZUBELDIA: Also we talked about PKI yesterday.

DR. COHN: Oh yes, well I guess that is a question of what, yes.

DR. ZUBELDIA: We need to fit it in somewhere.

DR. COHN: Well it is actually, we, I guess I make the point we all agree that enforcement and compliance is an important issue, okay, and so I think we need to be flexible. I don't think we need to be flexible for February, I think it is a little late to start messing around with that schedule, but we may have to switch around either the April or the May or do something, depending on what the department needs around enforcement and compliance. Because assuming the dates go as planned, think about it. I mean this whole thing has to be in place for October.

MS. TRUDEL: Yes, plus we are talking two more regulations, plan ID and attachments.

DR. COHN: Right. Well those will be the letters right?

DR. ZUBELDIA: No, no, final rules, no proposals.

MS. TRUDEL: Proposed rules. So right, there will be a need for deliberation and letters.

DR. COHN: Right, exactly, but not - but you are right, there needs to be letters, there needs to be a report. I apologize in regard to issues, documents (laughter), but I guess as I look at all of this stuff, to me the big issues that we may need to find some time somewhere in here, to scalp out for enforcement and compliance. So I think we'll look to Karen to assist us in terms of the timing, and I wouldn't be surprised if it might not be April and we have to move diagnosis to May.

MS. TRUDEL: What about procedure coding, can you talk about CM without talking about PCS?

DR. COHN: Yes. I think we could actually call it, this is an area I've decided I have to sort of recuse myself almost from the discussion. I mean I sat on the ICD 10 PCS technical advisory group, but as you know, I also sat on the CDPN editorial panel, so I am conflicted in about 12 different ways. But I really don't think that I can make a good comment about ICD 10 PCS versus CPT, which is really around the issues around unitary procedure systems.

And my own thought was just to maintain an ability to have hearings that can get out in two days, and if we are going to do one of those I think it should be a focused set of discussions that is really specifically on that topic. But that is my own person view and Kepa, Jeff, if you have thoughts about that one.

DR. ZUBELDIA: It would take more than two days to do both. I think we need to bring in some of the group issues, not just - but some of the payment issues - ICF.

DR. COHN: ICD 10 CM?

DR. ZUBELDIA: ICD 10.

DR. COHN: You know, I think Marjorie has some issues, but that one I worry a little less, I mean I think we will be able to do that one pretty well, and I'm sure there will be lots of people who have opinions about this one as well as advice to give us on CM, and we think we can break out CM and PCS, except the discussions.

Now does anyone see anything else on the horizon. I mean see in all of this the enforcement and compliance to be a bit unknown in terms of timing and all that. ICD 10 the timing may be right or it could slip a couple of months and it wouldn't be the end of the world.

MS. TRUDEL: Just one question.

DR. COHN: Karen, and then there is a question from Dan.

MS. TRUDEL: If Congress passes some kind of delay legislation, does that raise any issues or questions that the subcommittee would want to look at?

DR. COHN: I think that has to - limitation.

DR. ZUBELDIA: Probably have to send a letter with recommendations won't we?

DR. COHN: Well if Congress passes a delay, I don't think that that is a thing that we would write a letter, I mean I would just defer to the subcommittee.

DR. ZUBELDIA: It depends what is involved in the delay.

MR. BLAIR: Karen, have you heard anything recently?

MS. TRUDEL: There is a proposal in the Senate for a straight one-year delay.

MR. BLAIR: Yes, that's the new one, okay.

MS. TRUDEL: That's I believe the only one that is on the table right now in the Senate, and I don't believe there is any legislation at this point in the House, but I know they are talking about it.

MR. BLAIR: Okay. Well it sounds like it is not too likely. If there is nothing in the House and we only have, you know, a couple more months, and yet so many other things on the agenda.

MS. TRUDEL: Exactly.

PARTICIPANT: (Comments off mic) The Senate - yesterday.

MS. TRUDEL: Oh did it? Ah.

MR. BLAIR: Moved up meaning?

PARTICIPANT: For debate.

MR. BLAIR: Oh, for debate.

PARTICIPANT: (Comments off mic) Right now there is no opposition.

MR. BLAIR: Is there anything in the House?

PARTICIPANT: (Comments off mic) Is there a bill in the House. There's not a bill in the House, there was the backup plan in the House that - a delay. Great compromise.

MR. BLAIR: So actually anything could happen.

PARTICIPANT: (Comments off mic) I will tell you - mention in any delay -. We will have to monitor what happens.

MS. TRUDEL: Thanks Dan.

PARTICIPANT: (Comments off mic) The issue I wanted to raise Simon is in the last three weeks we've had several meetings here in Washington and you may have already talked about this, - the discussion has been about terrorism, but in two of the three groups the discussion has moved to the public health infrastructure. And the discussion in the public health infrastructure has gotten to the standardization of both nomenclature as well as, for lack of a better word, entry level data at the encounter.

DR. COHN: Could you tell me what forum you were referring to, where this discussion is taking place?

PARTICIPANT: (Comments off mic) The RAND Corporation held a forum yesterday and - held a forum the week before on these issues, and - has actually got, now has a subcommittee on these issues. The question is what data can be collected at an entry point that could be transmitted within 24 hours in a standardized way to some group that could determine whether or not there is an issue - Bioterrorism is a rather difficult issue.

The second part of that which - this group is pursuing is also what information could be syphoned out of laboratory systems and also put into some type of a public health infrastructure that would look for this.

The third issue is probably the easiest one to resolve, would be the need to look at the pharmaceutical industry to determine if there is an audience for a particular prescription or over the counter items that are being - but the question gets back down to standardized data that could be collected across all type of service on an initial basis or information that is already fairly standardized - and how would that work and how does it fit into the system - talking about, where there is some additional information that needs to be collect. And again the burden came up - adopting standards - which puts it into the subcommittee's lap.

The other issue that came up, at least in the - and the RAND which had Congressional members present - but both groups essentially said that if anything is going to work and it has the people crossing state lines in a public health situation, then it has to be some type of mechanism for universal ID which of course raises the whole issue which the committee has been stymied with for years and which we can't talk about it. But you might expect that those will come forward and give my recommendations - as part of -.

MR. SCANLON: The last thing you want them to do is to go off in another direction. There actually are fairly - activities underway in all of those areas, and you might just be building on what is already there and not creating something different.

PARTICIPANT: (Comments off mic) - if Congress wants something.

MR. SCANLON: Well but we are prohibited by law from doing anything really. So they are stopping it. If they want to proceed they would simply - no more language than that little delay.

DR. COHN: Dan, thank you for the comments. I think in many ways you have given us a transition almost to our December 13th hearing, which is really around the issue of clinical standards, and I think we hope to have Yasnoff come and reflect a little bit about public health issues, which I think you are beginning to talk about in this new world, - change any of the recommendations we have about that. I don't know that we need to at this point ponder over whether we are going to elect a clinical terminology tomorrow or whatever, but certainly there is a lot of infrastructure work with or without that needs to be occurring and standards set to enable all of this stuff to happen, which I think you are reflecting on.

As we know, six months ago archaean but interesting. Suddenly since September 11th it sort of becomes front page news. And I think we were asking Yasnoff to, on the first day, to talk a little bit about that. And maybe with that we ought to, I mean we have reflected I think on various placeholders - in view of if there is a year's delay, we obviously need to reflect on that sometime during hearings up forward, but who knows, I mean I've stopped trying to figure out what the Congress is going to do on this stuff, and so I don't think there is much point in discussing percentages or likelihoods, but we will react as is appropriate based on whatever happens.

And we have provided advice already that has been I think widely heard in terms of delays and issues around delays.

MR. SCANLON: Simon, for the February meeting, and even for the full committee meeting, we should think about a CDC presentation on the current communication system for notifying in an emergency and notify - diseases and so on, and what might be some of the new direction, some of the new - they are building on NEDSS, they are building on Health Alert, they are building on a survival - system that has been around since, oh for at least 50 years. This might be the opportunity to upgrade those to be a little more real time and employ some standards and bring them altogether.

But I think they've got things underway and we have a new bioterrorism office and preparedness office and maybe we could have them come in as well. It is not just CDC as you know.

MR. BLAIR: And you were referring to February?

MR. SCANLON: Well I was looking, we could either do this as part of one of the subcommittee meetings.

MR. BLAIR: There's a presentation in New Orleans the 13th of December.

MS. TRUDEL: I think the full committee would be interested in this.

MR. SCANLON: Would be probably February.

DR. COHN: Jeff, why don't you reflect a little bit about what we are talking about for the first day of the December meeting and then we will fold in these other pieces.

Agenda Item: Planning for December Hearings - 1st Day

MR. BLAIR: You betcha (laughter). Let me put it in context a little bit. For those folks that are around here, you may not know exactly where we are. In terms of, we are going down the process of selecting specific PMRI standards, the first phase of which is message format standards. The process to do that involved the questionnaire that reflected the guiding principles, and that was filled out by the SDOs and returned to us in the June, July time frame.

We also solicited comments and feedback on message format standards on October the 9th and the 10th, and we have made a first draft of a recommendation letter which has been, you know, distributed to our committee members for discussion. And Bill Yasnoff has indicated that he wants to make some additional modifications on that, and I am going to kind of incorporate Bill's and anybody else's comments or suggestions on that and get out, you know, version two by the end of this month, the 30th of November. So please, if you have thoughts on the letter, please get that to me before then so we can fold it into the next version.

This is all leading up to our December 13th hearings, actually I shouldn=t say hearings, our December 13th meeting, where we would really like to make as much progress on that letter as we can. Now the way I have been viewing these draft letters is that they are as much a vehicle for highlighting issues as they are getting the wording down at this stage, these early draft letters, and they have begun to highlight a number of issues, and Simon and I talked about this a little bit.

We would like to take advantage of the morning of December 13th to have members of the four SDOs that we are focusing on right now, which is HL7, DICOM, NCPDP, and IEEE, that all have implementable standards. Most of them have market acceptance, but they all at least have implementable standards. And in terms of those issues, we would like them to be able to answer questions that we begin to gather during these next four or five weeks, so that in the afternoon we can be armed with answers to as many of those questions as possible to refine the recommendation letter.

So that was kind of our game plan, having Bill Yasnoff there also to give us an update that morning as well on NEDSS, the National Electronic Disease Surveillance Systems, and the other activities that CDC is working, especially with HL7 in terms of message queries for immunization status and I think there is another one on infectious diseases that they are working with, and the DEEDS system. So all of those things might be thought things that we may or may not want to either include or reference in our recommendation letter.

So anyway, that is our game plan for the 13th. Are there comments, suggestions? Let me add one other thing since I didn't hear any responses on this (laughter). In conclusion (laughter).

DR. COHN: More time or more coffee (laughter).

MR. SCANLON: Can I just back up for a minute. These are the preliminary thoughts about PMRI standards, right?

MR. BLAIR: About the message format.

MR. SCANLON: Oh, message format, okay.

MR. BLAIR: Yes, and we are looking, our target that we set in the report was we set a self-imposed target for ourselves of 18 months to provide recommendations on message format standards, well to provide recommendations on whatever we picked was the first one, which is message format standards. So the December meetings are to help us come a long way to getting to that point, with the idea that, you know, hopefully we could have a letter in place by February.

I might mention one other piece, and that is that when Margo Amateophin gave us the briefing that she had pulled together, the analysis from the SDO reports, there was a number of list of issues and questions, and I have circulated that around to our subcommittee, asking your thoughts on that. I have not gotten any replies on that, and so please either look at that or I will just assume that your feeling might be as mine is, that some of the questions and issues won't be really that useful to us in going forward and selecting the standards. For example, one of the issues was to press the SDOs somewhat further in terms of market acceptance of their standards, but if they don't the infrastructure in place to be able to gather that data, then I don't know how much value it will be to go back and ask them for more information on that, and I don't know, even if we get that more refined, whether that will be helpful to us.

But that is the kind of a thing that was in the letter, so you know, my inclination is that we don't need to necessarily have the SDOs report more on those, but please take a look at that email and let me know if there is some items in there that you feel we should go back and get.

DR. COHN: And Jeff, I think having said that, I think I'm going to stretch this, we send it to the committee just as a please respond if appropriate. Just don't bring it - not that everybody doesn't get a hundred emails a day, but I would suspect that most of us -

MR. BLAIR: Keppa gets 120.

DR. ZUBELDIA: 160.

MR. BLAIR: 160.

PARTICIPANT: I have a question. How does this, Jeff, fit into the February meeting?

MR. BLAIR: The activities on the 13th are not really related to the -

DR. COHN: Which February meeting?

MR. BLAIR: Oh you mean the full committee meeting? We would hope that by the full committee meeting we would have a recommendation letter that they could review and approve, so that we could send it on.

PARTICIPANT: And do you see any activity needed between December 13th and the full committee meeting?

MR. BLAIR: My, you know, you never know exactly how this will play out. There still may be some open issues at the end of the day on the 13th, and maybe we will need to either request additional information or whatever. But if we have got the letter in fairly good shape, then we have got the month of January to maybe flesh out some of those issues and refine it or find some other wording. And we are going to meet again in February, and although this is not on the agenda for February, if it is a matter of, you know, just a little bit of minor tweaking or something like that, we have at least a chance to look at the letter again. I know, it is not on the agenda?

DR. COHN: Well no, but I think we will provide that opportunity. It is a lot easier to do this in person than it is over the phone.

MR. BLAIR: Is that answering your question.

PARTICIPANT: Yes. I just knew that it was going to be a tight agenda for the subcommittee in February, so I didn't know if there was a need.

DR. COHN: We will hold time and make time. I think we will just probably put a little placeholder in for some time to discuss it, because action items obviously have priority. Jim.

MR. SCANLON: Simon, I think that potentially another factoring into the work plan here, probably by the February full - we would want to have a draft of the annual - implementation as well.

DR. COHN: Oh yes. Ooh, yes you are right.

DR. ZUBELDIA: We are going to have a hearing on implementation December 14th.

DR. COHN: That's right. Thank you for that, that is a day two discussion for our December 14th meeting. Actually we haven't been here mulling about it, just recognizing the annual report is going to look significant different, well not significantly different, but different than previous years, because as much as the administrative and financial transactions play an important role and all the other identifiers and all these other pieces, some of which we will receive before the end of the year, would be helpful, we obviously have privacy which is another major piece, and we need this to get input from the Subcommittee on Privacy and Confidentiality, we probably want to have included around privacy, and that is going to be a fairly large piece of that I think recommendation or report.

MR. BLAIR: Let me just make one last comment with respect to the first day. Actually it is with respect to what is in the packets here. Jackie and Gracie made copies of the letter, our first draft of the letter, but in addition to that, you know, as part of the blind guys learning process, I went back through all of the testimony, the hard copy testimony that we had received on the 9th and 10th, and I made my notes and we put them in a spreadsheet, and I just thought for your own information I shared them with you.

So copies of everyone in terms of the format that I broke it down into is there. That may help you as you go through the letter, if you want to double check back on what we heard in the testimony and who said what and how that balances against some of these things and whether there is something in the testimony that you felt wasn't reflected in the letter. So that is there for you.

DR. COHN: Jeff, thank you, and I will tell you that this is excellent - blind, but sometimes getting close to it though is a tough thing (laughter).

MR. BLAIR: You didn=t know the other part of my nature did you (laughter).

DR. ZUBELDIA: Just for your information, it is printed like in four point (laughter).

MR. BLAIR: Was I being overly generous. I thought seven point (laughter).

DR. ZUBELDIA: It is excellent material.

MR. BLAIR: I thought it was sent electronically to you, so you may be able to read it easier in the electronic version.

DR. ZUBELDIA: No, this is readable. It is okay.

DR. COHN: It is. I was just sort of clarifying the right focal point there. Just giving you a hard time. I really do appreciate it and thank you for putting it out. I mean we talked about it and these things sort of get lost in email sometimes too.

MR. BLAIR: Maybe I could print it out on legal size paper, which is always a hassle.

DR. COHN: That's right, exactly.

Agenda Item: Planning for December Hearings - 2nd Day

DR. COHN: Let's move to the second day of the hearings on the 14th. Jim has actually asked the awkward question, which is why we are doing the second day of hearings. It has to do with I think getting the gauge on implementation status. Now Kepa, I think you brought up a question earlier that I want to go back to, which is one of the questions we had had for the second day, was do we want to do anything updating around PKI.

And I think really the question is do we want to do it then, do we want to do it in February, or do we want to do it both. And by February I mean the full committee meeting. We heard yesterday that the full committee wants an update. Do we also want something on December 14th?

DR. ZUBELDIA: What I had in my notes was to get an update on the electronic signature from a multi SDO group.

DR. COHN: Okay.

DR. ZUBELDIA: Just a 10 minute update, that is it. I think that is all we are going to have room for in half a day, if we want to do the implementation status and all that.

DR. COHN: Okay, so very brief. Would it be, should we ask them to come down and do it or you just want to ask them for a written report, give them the option, since - happening in February anyway?

DR. ZUBELDIA: Sure, we could go either way.

DR. COHN: Karen, you are nodding your head in the wrong direction. What is that?

MS. TRUDEL: Oh no, I was just thinking a written report might be the best compromise.

DR. COHN: Yes. Why don't we ask them for -

DR. ZUBELDIA: Yes. Just ask - for it.

DR. COHN: Yes, why don't we ask them, because I think we obviously want to have them in February I would imagine for this panel or whoever they feel is appropriate. It probably is respectful not to make them come out every other month to tell sort of the same thing.

MR. SCANLON: For the February full committee meeting again the agenda is starting to fill up already, but what was discussed a little bit yesterday was the idea of - PKI from the states, from the Western Governors Association and from the department and others. Is that a panel or just a submission?

DR. COHN: Well it sounds like it is going to be probably not a big panel, but a panel, probably a couple of hours, and again, the issue of PKI and digital signature standards, they are different but they are all sort of the same. And there are differences but it isn't so striking. I think we can better figure out, like you said, for my view at the end of the day is if I am a provider, I'm going to be very unhappy if I have to use a whole set of PKI pieces and biometrics with the DVA and a different one with United Health Care or a different one with Kaiser Permanente, and you know, it is just going to be the old days of multiple different log ons to every different system, and we'll just raise the ante a little bit. But we will see where they are on that.

And as I said, Karen is going to have Kepa take the lead in terms of trying to, in John's absence I am delegating authority here (laughter). By yes I was hoping we could have Kepa sort of help identify who should be there and all that. Is that okay, Kepa?

DR. ZUBELDIA: Yes.

DR. COHN: Okay. So let's talk, I think taking PKI off, I mean digital signature, and sort of hoping a written report to us so that we can review for that report, and might be able to do reference then in the annual report. And what else do we want to have. Kepa, you had mentioned a couple of things in email -

MS. TRUDEL: How much time do we have for that day, for the 14th. Is it a 1 o'clock adjourn or 3?

DR. COHN: Well let=s talk about what we want to put in it and then let's figure out what we want to, how long we want to stay.

MS. TRUDEL: Okay, I just wanted to know if there are any constraints.

DR. COHN: Well I think we want to get home that night, that's a constraint.

DR. ZUBELDIA: What else I have in my notes, there is an issue with the survey that Folkian and Gray have been carrying out in the past. They were acquired by another publisher and the other publisher has decided to discontinue that survey. So there is no more Folkian and Gray progress report.

MR. SCANLON: Kepa, I think they didn't even, they are not even planning to publish the results of the latest survey.

DR. ZUBELDIAN: So there is no 2001 or 2002 survey.

DR. GRIFFITH: Can you explain what that survey was.

DR. ZUBELDIA: Well Folkian and Gray used to send a questionnaire to essentially all the payers, all the clearinghouses, - vendors, PPAs, lots of covered entities, and produced a book about an inch and a half, two inches thick every year, that had the status of electronic data in healthcare. And as part of the survey, they had been asking questions about the status of X12 implementation, who has implemented what transactions for whom, about connectivity, connectivity to clearinghouses, transaction volumes on electronic transactions, and it was a very useful report. But it is no longer available.

PARTICIPANT: Presumably that is because the economics of producing it were not favorable to publishing it.

DR. ZUBELDIA: Yes, the publisher has decided not to do it anymore.

PARTICIPANT: That=s why (laughter).

MR. SCANLON: They had a charge for it but you are right -.

DR. ZUBELDIA: It had been going on since 1990/1991, and so it had a very good track record. It was always the same time of survey to the same people, so it is gone.

MR. BLAIR: How much was it?

DR. ZUBELDIA: It was about $450.00 a copy. But it was very widely distributed.

PARTICIPANT: Did people buy it?

DR. ZUBELDIA: Yes, lots of people bought it.

DR. COHN: So Kepa, are you going to take it over (laughter).

DR. ZUBELDIA: No, no. What we have available is surveys conducted by the government group, and the government group has been conducting a longitudinal survey to the same sample population for the last year and a half, and they do a trimester survey.

DR. COHN: We should ask them to come in.

DR. ZUBELDIA: Phoenix Health conducts a volunteer survey on their web site, and they get a lot of responses. However, responses only come from people that are active in the - health - other people are already interested in the topic. - Net could conduct a survey of their membership as far as implementation and they have been conducting a survey. I haven't seen the results of the latest round. And then there could be other progress reports. Maybe CMS would have some feeling for what their providers are doing. But that is about all we can get from surveys out there that I know of.

DR. COHN: Is there anybody that can report, I mean vendor readiness I think is an ongoing issue that I think we hear, we continue to hear, whether it is - an excuse for not being ready or whether there are really significant issues there. Is there any group that would be able to represent adequately, and I don't think we need to hear from every single vendor how ready they are, but is there somebody? Do you think Gardner would give us a broad view or do you think there is actually somebody in the IT community that can represent that?

DR. ZUBELDIAN: We could hear from AFEC, but I know that there is not any survey from AFEC on the vendors. Dan, do you have your -

PARTICIPANT: (Comments off mic) Well HEMS now is merged with CHIN - it might be worth -.

MS. JORDAN: Simon, my own experience has been that vendors are keeping it real close to their chest.

DR. COHN: About whether they are going to be ready or not?

MS. JORDON: Well what their readiness plans are, and more importantly what they obviously want to include, at what release level and what format they are going to support.

DR. ZUBELDIA: The vendors have, some vendors have caught a lot of flak because they are going to release a non-HIPAA compliant version this spring, and then another HIPAA compliant version the summer or fall of next year. And because of that, most vendors don't want to talk about it.

MS. JORDAN: It becomes a provider issue for them. If a vendor comes out and says, you know, we are not going to issue HIPAA compatible software until December of 2002, then there is going to be scurrying around of the clients, justifiable so. So vendors are not being very forthcoming. In fact, the vendors that I have talked and vendors that clients have talked to are getting absolute mixed messages from them. You are basically talking to sales people and the sales people are not, you know, I used to work for a vendor, and God you never told the sales people anything because they would - and they would always oversell what you had anyhow. So the sales people are really not real knowledgeable and of course they are saying we can supply you with anything.

DR. COHN: Yesterday (laughter).

MS. JORDAN: Yesterday, and there's no cost (laughter), and the up bringings are easy and you know.

MR. SCANLON: Well you know in a way that is why you almost need an industry analyst like Dick Gardner, where they don't have an axe to grind, well they have an axe to grind but it is not that - and you know, something a vendor couldn't say. Gardner can kind of say in terms of assessment. They have their own.

MS. JORDAN: You are not going to get anything if you tend to be vendor specific. I would think Gardner wouldn't violate that confidence. And I think that is what is really needed in the industry, something that is vendor specific.

MR. BLAIR: Question Helene and I guess Kepa also. This is kind of a surprise to me, because if they, at the conference floors during these last several years, the vendors have been boasting about them being HIPAA compatible and compliant. So for them not to be ready at this point is a real surprise to me. The other piece is, is it, I could understand it, a lot of vendors are struggling financially and it may be very difficult for them to do it, those are probably the smaller vendors. Is it a matter of the vendors that might be in financial trouble versus the major vendors?

MS. JORDAN: I'm not accusing them of not being ready. They may very well be ready, but they are just not releasing that information. That is the issue. And when I talk about vendors I'm talking about HIS vendors, I'm not talking about, some people include vendors clearinghouses when they talk about vendor, building services and so on. I was only talking about HIS vendors or medical clinician practice vendors. They may very well be ready.

One of the issues from the provider side, both institutional and professional, is what release - they currently are on within their system, and what release - I know are on maybe 4 and it is going to be release 8 that's going to be compatible, so they are going to have to, basically if they are that far behind, one, their existing software is sunsetted by the vendor, but secondarily they are basically going to have to do a reinstall, because there is no way you can go through four upgrades in time to be, the provider to be compliant.

So I don't think it is an issue of them not being ready. It is just we don't know what their readiness status is and I can't blame them for not telling people what their status is.

DR. COHN: Well I think we need some objective data on this one. Certainly one would observe that if they work in a compatible, they would be saying so. So but not knowing that is an issue. Now Dan had raised his hand. Do you have a comment?

PARTICIPANT: Interesting comment. I think you also need to look at clearinghouses, because the physician community especially is going to probably be relying on clearinghouses to each know what the status of that is.

DR. COHN: So we probably need to have AFEC.

DR. ZUBELDIA: We need to have clearinghouses and I would call them out, just two or three clearinghouses or maybe AFEC to testify.

DR. COHN: Doesn't AFEC represent the clearinghouses?

DR. ZUBELDIA: Yes, but it is always better to have the horse testifying, have the things going from the horse's mouth. The reason why I am saying that is it is not clear in the community that the clearinghouses are going to be ready, and I know they are going to be ready. I've seen their test reports come into Claredi, but it is not clear out there, and the clearinghouses have been very hesitant to say that they are going to be ready. They say not the vendors. There is a huge competitive issue here and nobody wants to say anything in public. So I think it is important, because the clearinghouses essentially become the contingency plan. If the vendors are not ready, everybody is going to have to go to clearinghouses, at least as a contingency plan, and it has to be known what the readiness is, and right now they just don't want to talk about it.

MS. JORDAN: But you know, there is another whole genre here that needs to be considered and that is the medical practice software, but there's a whole bunch of other software that is out there that is going to have to be compatible. Home Health software is not collecting the data elements. I did the readiness assessment on the ambulance service, and as you know, in the 837 professional there is a whole series of data elements that are going to have to be submitted with an ambulance claim, and their software, and they've got one of the competent in the nation, does not store the data elements, and you know this is my mantra is that if it is not stored, you can't send it forward.

DR. COHN: Sure, I agree with you. Well I guess we need to find, I mean there is an issue here again with the appropriate level of detail I mean, and I think we need to stay relatively high on the vendor readiness issue, and I do know that if we start going into the various subtypes of information we are going to get, I mean this could be like a - because there is obviously many different types of vendors and many different niches in the industry. But the question is how do we get the appropriate level of view that can be reflected as well it continues our responsibility to sort of keep tabs on what is going on in the industry.

It sounds like AFEC talking may be an appropriate level if indeed there is one or two major vendors, but I not clear that we really need a bunch of clearinghouse vendors to come and tell us that they are ready. And of course in public I am sure they will tell us that they are ready.

MS. JORDAN: Simon, could I suggest maybe AFEC for the clearinghouses, and maybe even for payers because they are also represented there. And what Dan suggested with using CHIN for the HIS and the practice medicine software. And perhaps they could even do it sort of in a blinded, I don't know if they would. Dan do you know if they would even do it as a blinded kind of a report, where they could just say that, you know, vendor XYZ has this kind of a time deal. I don't know if they have a staff to do that or not.

PARTICIPANT: I can't speak for them. One of the thoughts that you said though that just popped in my mind is I don't know, if this is February it would be interesting to know if they could also face questions from the committee on the survey that they do during the meeting - a few weeks ahead before that.

DR. COHN: Well we are meeting this December.

PARTICIPANT: Oh this is for the December meeting.

DR. COHN: So we can talk to them about getting more information for us for February.

PARTICIPANT: I'll get hold of Steve.

MS. JORDAN: And their meeting is in January.

DR. COHN: I think January. As I said we'd like to get obviously what information we can by year end, though obviously if there is more information before the report we'll include that.

PARTICIPANT: The other group that you could talk to would be the GPA group out of Bethesda, which represents-

DR. COHN: SPBA?

PARTICIPANT: GPA.

DR. ZUBELDIA: SPBA.

PARTICIPANT: Yes, which gives you a sense about where the smaller groups are. And they would be able to reflect I think also on where they are facing problems with vendors and clearinghouses. There are also the groups that many times are being - positions and some of the smaller providers.

MS. JORDAN: MGMA.

DR. COHN: Oh there's a question about MGMA, would they be -

MS. JORDAN: That would be a good one. I could talk to Ron Terrent.

DR. COHN: Good.

PARTICIPANT: I think it would still be good to start off with Gardner or someone like that.

DR. COHN: Oh yes. We are not in any way disagreeing with that one. We are just sort of adding some depth in this particular area, because I really think an awkward question is gee are the vendors ready. Obviously Gardner can comment about that as well as every other aspect of the industry. Other thoughts on what we should be doing during that time. I think we are getting I think some focus where we want it. Jim, as you think ahead towards putting this together, are there any groups that you think we need to be hearing from.

MR. SCANLON: Well I think we will just start, Simon, by updating the factual situation with respect to where the regs are. I mean the annual report and then, I think last year we actually had hearings and we identified about four or five issues that were concerns about - implementation. We probably still have those plus a few more.

DR. COHN: Yes. I mean I think the only question in the midst of all of this stuff is I mean we could, and I'm not sure, as I say this I don't know that I want to go there, but we could get some professional societies in to represent, or not so much professional societies but - hospital providers, physician providers and all that too. But I don't know that they know, I'm not sure that they would add a whole lot to the discussion. Maybe the consultants, who would likely get into more of the political and lobbying stances of their particular positions.

MR. SCANLON: And you know what some of them have already said in their letters.

DR. COHN: Well some of them have changed.

MR. SCANLON: Have they?

DR. COHN: Well I mean I'm sure you have seen letters that have gone to Congress that are somewhat different from testimony that we foresee. Let's put that as a question mark, because I think -

MR. SCANLON: (Comments off mic) Well - would actually be a mistake - you might want to hear from -

MS. JORDAN: They usually have proprietary software now, so there's really not an issue of them becoming compatible, affecting the industry as a whole. One of the ones that I was just thinking about was what about HISV, - are supporters, HISV and Jeff, you did that study of the vendors several years ago that might be a starting point for that. Again I think it has to be blinded because of the competitive issues.

MR. BLAIR: I qualify.

MS. JORDAN: No, yeah right.

MR. BLAIR: Never mind, just it is Friday morning (laughter).

PARTICIPANT: No more coffee for you (laughter).

MS. JORDAN: I'm just saying that I think the report from the vendors, whatever report comes out of the study has to be blinded in order to protect the competitive issues that are involved, and I think you have to assure the vendors that that is going to occur. But at least it would NCVHS a handle rather than just this sort of just what we hear. I mean I am hearing this from my clients, I'm hearing it from individual vendors, but I can't report on the industry as a whole. And I think that is what you need to have in your pocket. But I think the only way that you are going to get it is to assure the vendors that their time tables, their readiness, is not going to become general knowledge.

DR. COHN: Will I think that is why we are looking at the level of the consulting groups and all that, because I think they can give us more statistics and relative weights and all of this as opposed to asking, and I would certainly believe that if we call HBO, I mean your choice of large vendors in for public testimony on their readiness, I mean I'd sure say I was ready regardless and I'm not having any problems, so I don't know if there is, I mean and I would be saying the same thing and I don't think that there is any reason for them not to, because I actually think that they probably will all be ready. But it would probably be reassuring to hear some other views, as you described, some blinded views.

Now any other thoughts for this?

DR. ZUBELDIA: Well I understand the governor group is releasing a research note this week, I don't know if it has been released yet or not, and it says something like they give a 40 percent chance of the vendors being ready on time.

DR. COHN: Well let's have them come in and testify to us. I mean I assume that they are willing. Now is there anything else we need for this particular hearing? I mean it is looking to me, I mean I'm just trying to think, we'll have to put this together and sort of, I wouldn't make any plane reservations, I mean when we could leave on Friday, I sure wouldn't make a 1:30 p.m. reservation flying out. I think the questions is -

MS. TRUDEL: Why don't we try to cut it off at 1:00 p.m.

DR. COHN: Well I guess that is a question. I don't know, I'm trying to, yes we probably, I'm just sort of looking, we probably can. I'm just trying to think of whether, I think probably realistically that probably makes sense. I'm just trying to figure out whether we should tell people to make 5 o'clock reservations leaving or 3:30 p.m.

DR. ZUBELDIA: We'll probably have to go on to 3 o'clock.

DR. COHN: I would say I would hold till 3, recognizing that, I mean the problem gets to be that we actually have to hear from people and just have to figure out what it all means.

DR. GRIFFITH: Well in this day and age you will not make a 5 o'clock reservation if you leave here at 3.

DR. COHN: Well but I think the issue is that if we stop at 1, people will likely try to get 3 o'clock flights, and this way we'll say sort of like people should be looking at 5 o'clock flights and we'll modify things to support that ability.

MR. SCANLON: Save time after the presentations, Simon, for discussion.

DR. COHN: Some discussion, exactly. Okay. Now other thoughts, questions, comments. I mean I think we did a pretty good job designing at least the pieces associated with that Friday session. Karen, do you have any questions from all of this?

MS. TRUDEL: No.

DR. COHN: Okay. Now are there any other comments from the subcommittee. I guess I should mention since we went around with the introductions, Ted Shortliffe has arrived. My understanding is did you want to announce change in status?

DR. SHORTLIFFE: Well I have talked to Marjorie and Jim and decided that I need to reduce my time commitment a bit at NCVHS, so I will focus on the NHII workgroup where I've also been a member and not be coming to these meetings.

DR. COHN: So you will be resigning from the subcommittee.

DR. SHORTLIFFE: So I'll be resigning from the subcommittee.

DR. COHN: Well I obviously want to thank you for your involvement in the activity and obviously as other issues come up you are more than welcome to come back and rejoin us.

DR. SHORTLIFFE: Let me know if a question arises I can help with.

MR. BLAIR: Can I just mention, because you know, Simon was telling me this last night, that you know, really grateful for the time that you have spent on the subcommittee and that you really have helped us and made a contribution, you know, for the time that you have spent and we are very grateful for that.

MS. BEBEE: I have a question. We left a question mark for May 29th and 30th I believe, so that is still open for what the topics will be?

DR. COHN: Yes. I think that really the question is we move off into April, I mean there are a host of issues that we've got to deal with, and right now enforcement and compliance is the big unknown in terms of timing, and I would give probably a 50 percent bet as I think about it at this point that we may wind up putting a new diagnosis off to April and May. The question of course is whether, if there is a delay in Congress for HIPAA, then it changes the timing of the enforcement and compliance rule. So who knows, but I'm saying if things go along as scheduled, we are probably going to have to get into that sooner rather than later.

But we do need to wait for HHS to be ready to take some input. I don't think they are quite ready yet. So you are right, at this point we are not going to schedule the topics for May, but just everybody needs to know that it is a little further out on the 2002. The dates are set, the topics get to be a little fuzzier, I mean how we sort of schedule things around, and we will just continue that as an open discussion.

Other comments, questions? Suzie, does that help? As you have said, this subcommittee has a history of being a pretty active subcommittee. I don't see the work unfortunately getting any lighter anytime soon, and certainly as we move towards implementation, the issues get to be even more important, so we need to make sure we pay a fair amount of attention to that.

Okay, with that we will adjourn the meeting. We will reconvene at 10 o'clock upstairs for the full committee. Thank you.

(Whereupon, the meeting adjourned at 9:45 a.m.)