[This Transcript is Unedited]

Department of Health and Human Services

National Committee on Vital and Health Statistics

Subcommittee on Standards and Security

March 26, 2003

Hubert Humphrey Building
Room 705-A
200 Independence Avenue, S.W.
Washington, DC 20201

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

TABLE OF CONTENTS


P R O C E E D I N G S [9:15 a.m.]

Agenda Item: Introductions and Announcements - Dr. Cohn

DR. COHN: Good morning. Would everyone please be seated? We’ll get started here in a minute. Good morning. I want to call this meeting to order, this is the second day of two days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The Committee is the main public advisory Committee to HHS on national health information policy. I am Simon Cohn, chairman of the Subcommittee, and the national director for health information policy at Kaiser Permanente and a practicing physician. Obviously want to welcome fellow Subcommittee members, HHS staff and others here in person. As I mentioned yesterday, given the uncertainties of the international environment I want to thank again all the Subcommittee members for making the trek out here to join us for this meeting.

I think we also once again need to acknowledge the valiant efforts and sacrifices being made by our military personnel, both men and women, in Iraq as we have this meeting today.

Obviously we also want to welcome those who are listening in on the internet, and I do want to remind everyone in the room that when you’re speaking speak clearly and into the microphone, and if you would please identify who you are since the people on the internet don’t know who’s speaking.

Today we continue our discussions on a number of different items. We’ll start out with a discussion with WEDI on ways to improve and stabilize the HIPAA process. We’re also going to be having some discussion about contingency planning related to the October implementation of the administrative and financial transactions rule. We obviously want to thank Jim Schuping, Ed Jones, and Steve Lazarus, thank you for joining us today for this session.

After that we’ll follow up with a discussion with Jared Adair and CHI, even though she’s not in the room I think she’s already heard our congratulations on the formal announcement by the Secretary on Friday of the initial set of the CHI recommendations for use in the federal government and we’ll be briefed on this later on this morning.

Then we’ll be reviewing information from ASCA database, I thank Mike Fitzmaurice and Steve Steindel for preparing a document on that. Finally we’ll be discussing the status of the ICD-10 cost/impact study, and I think with that we’ll be adjourning by about 12:30 or a bit after lunch.

With that let’s have introductions around the table and then around the room. For those on the National Committee I would ask if there are any issues coming before us today for which you need to publicly recuse yourself, please so state in your introduction. Jeff, would you like to start with the introductions?

MR. BLAIR: Jeff Blair, Medical Records Institute, vice chair of the Subcommittee, member of AMIA(?), ASTM, HL-7, and HIMSIS, and there’s nothing I need to recuse myself about.

DR. HUFF: Stan Huff with Intermountain Health Car and the University of Utah in Salt Lake City. I’m involved as a co-chair of the LOINK Committee. I’m a vocabulary terminology co-chair within HL-7, a former chair of HL-7, and I’ve also been a former member of the SNOMED Editorial Board. I don’t know of any business that we’re doing today that I would need to recuse myself of.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the National Committee and staff to the Subcommittee on Standards and Security.

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the full Committee and staff to the Subcommittee.

MS. BEBEE: Suzie Bebee, NCHS, CDC, staff to the Subcommittee.

DR. LAZARUS: Steve Larazus, president of Bounty Information Group and immediate past chair of the Workgroup for Electronic Data Interchange.

DR. JONES: Ed Jones, chair of WEDI, I’m also a commissioner with the Electronic Health Care Network Accreditation Commission and a private consultant.

DR. SCHUPING: Jim Schuping, chief staff executive for WEDI.

MS. AULD: Vivian Auld, National Library of Medicine, staff to the Subcommittee.

MS. PICKETT: Donna Pickett, NCHS, CDC, staff to the Subcommittee.

DR. FERRER: Jorge Ferrer, medical officer, CMS, staff to the Subcommittee.

MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, and executive Secretary to the Committee.

DR. ZUBELDIA: Kepa Zubeldia, Claredi Corporation, also a member of WEDI and co-chair of the WEDI Security Pie, and there is, I understand that WEDI has engaged one of the Claredi lawyers for one of the topics that we will discuss today. As independent counsel for Claredi, he’s also independent counsel for WEDI, so there may be a conflict there. I will tell you the whole story. Claredi hired a Washington lawyer to study something for us, he did great research, then WEDI hired the same lawyer to study the same thing for WEDI.

MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services, staff to the Subcommittee.

MS. SQUIRE: Marietta Squire, NCHS, staff to the Subcommittee.

DR. NACONEY(?): Frank Naconey, American Dental Association and chair of the DSMO Steering Committee.

DR. SUJANSKY: Walter Sujansky, independent consultant and advisory to the Subcommittee on PMRI terminology standards.

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

MS. ROTH: Dominica Roth, HHS staff.

MS. BICKFORD: Carole Bickford, American Nurses Association.

DR. COHN: Well, thank you. I think before we begin the WEDI panel, obviously we would ask Karen Trudel to give us a big of an update on the HIPAA regulations. Karen?

Agenda Item: Status of HIPAA Regulations - Ms. Trudel

MS. TRUDEL: Well we haven’t published any since the last meeting so I guess that’s not a surprise. The next regulation that is expected to be published is the National Provider Identifier Final Rule. It is nearing the end of the departmental review process and I believe we’re anticipating at this point that that regulation will be published sometime in the summer timeframe.

As far as the attachments proposed rule goes, we have heard from Health Level Seven, which is the standards developing organization for one of the two standards that we would have been proposing that they essentially have a better idea, that they’re developing a new XML based standard and that they would like us to not go ahead with the proposed rule right now until we get a chance to look at it and assess it. And we understand that they will be sending us a formal request in the next few weeks I guess and we’re awaiting actually being able to see that.

DR. BLAIR: Did you say that’s for claims attachments?

MS. TRUDEL: For claims attachments, yes. In addition to regulations, I’d just kind of like to update the Subcommittee on some of the things that we’re doing with respect to outreach. We have developed a series of technical information papers, it’s a series of ten papers, and they look like this, and they are a set of papers that provide guidance, especially to providers. And they include things like how to tell whether you’re a covered entity, some key dates, what are the transactions, is your software vendor or billing service ready, what to expect from your health plans, what you need to know about testing, trading partner agreements, and enforcement. And we will have already published the first one in the series and we will be rolling these out over a period of the next couple of weeks. They will be on the CMS website and they are essentially available to anyone who wants to reprint them.

That’s about all I had to report.

DR. COHN: Questions from the Committee? And Karen I will start out with the first question which is with the changes likely to be occurring with the claims attachments format, etc., what is that going to do in terms of timing of the Notice of Proposed Rule?

MS. TRUDEL: It really depends on the new standard and when it’s completed and balloted. It’s my understanding that HL-7 expects to have completed that process I think in June. And if that’s the case we’ll need to take a look and see if we need to make some changes in the regulation and then move it forward, so I would say we’re talking about at least a few months after that before we’re ready to have a document ready to go forward. Is there something, would the Subcommittee want to be briefed on that new standard? Could we put that on an agenda for a later meeting, if we can get HL-7 to come in and do a brief on it?

DR. COHN: Sure, well if it’s done in June it might actually be appropriate even to bring it up at the full Committee to sort of let everybody know about it. I guess the other question is of course is my understanding was is that the claims attachments is a collaborative effort between X-12 and HL-7, will they all be approving it in the June timeframe?

MS. TRUDEL: We’ve just reached the extent of my knowledge on this issue. I think that’s one of the things that we would want to talk about when we begin to look at the standard, their part of the standard, how it fits in with the X-12 part of the standard, which is basically the enveloping part of it and see how that all hangs together.

DR. COHN: Ok, other questions? Jeff and then Michael.

MR. BLAIR: Karen, I’m assuming you’re familiar with last Friday’s announcement, Tommy Thompson’s announcement in Detroit?

MS. TRUDEL: Yes.

MR. BLAIR: The only thing that I got to see about that was the press announcement, and in the press announcement it referenced the standards that were being adopted by the Consolidated Healthcare Informatics Initiative, and that it related to the NHII which, of course, was the concept set forth by the NCVHS. But there was nothing on, how do I want to say this, the standards appeared to be consistent with what we recommended, and of course that was part of what we recommended, but in the press announcement there was not further explanation so I don’t know whether this was considered to be HHS going forward with the guidance and the incentives for the message format standards that we recommended or how should we interpret this? Was it parallel or what?

MR. SCANLON: Jeff, it’s Jim Scanlon, let me try to explain. What the Secretary announced last Friday that the Federal Health Care Enterprise, which is HHS, DOD, VA and some other health care agencies as well, would be using a suite of about a dozen standards to exchange clinical data. And those standards were mostly, they were the standards that the NCVHS recommended, the messaging standards you remember as part of the first PMRI set, as well as LAB LOINK. And that’s as far as we were able to go at this point. What the Secretary announced was that the federal health care agencies would be adopting these and we would be orienting our future systems development in that direction, that would be the framework we would be going, there’s nothing else about incentives, it’s purely a standards convergence and a standards adoption activity for the Federal Health Care Enterprise.

Obviously the Secretary, as he said, he would hope that the industry would follow suit and use this sort of leadership and direction as the way they want to direct their investments as well. But other than the announcement there’s nothing in terms of specific investments, that would follow in terms of implementation in the federal agencies. The federal agencies, the Indian Health Service for example, the VA, the DOD, in fact are using these standards to various degrees already. In their systems development work they would have to plan for full incorporation and full implementation as we go along.

Is that helpful? I know it was a relatively terse announcement and it just listed, you know the HL-7 was one of the standards, the IEEE standard was one of them, the NCPDP scripts was another one, LAB LOINK was another one, I’m forgetting, DIECOM was the other.

MR. BLAIR: Could I try to understand this refinement then? When we set forth the recommendations we indicated that these would be HIPAA PMRI standards but they would be guidance to the industry. It sounds like this announcement did not do that, what it did was indicated what CHI was doing and adopting these standards, which happen to be parallel to our recommendations, and that was one of the recommendations we had was early adoption but there’s no reference that this would be HIPAA PMRI guidance to the health care industry as a whole. Is that correct?

MR. SCANLON: Well, I think it depends on how you look at it. I think the vehicle that the Department was using and the federal agencies were using was an example and an exertation to the industry to use it. There may or may not be any further guidance in that direction. I think that is guidance, I think the Secretary views that as guidance. I mean other formal guidance I don’t think anyone is envisioning though that’s certainly something. I think the strategy being used here is the strategy that has been used many times before in moving innovations. In the odd instance where the federal government was the first to, or one of the early users, to promote wider adaptation. It’s happened in health insurance, it’s happened in other technology areas, it often happens through federal procurement and federal activities, where the standard is not one regulated or mandated, it’s one where by example and by consensus and by purchasing power and so on, which is pretty much what the Committee recommended. So again, I don’t think, I’m not sure there’s going to be any more formal guidance on those, though that’s conceivable as well.

MR. BLAIR: Thank you.

DR. COHN: And Jeff, you might, obviously Jared Adair will be here later on today so I’m sure you can further explore some of those questions with her. Michael and then Marjorie.

DR. FITZMAURICE: I don’t think I had a question on this one, but thank you, I’ve got thoughts.

MS. GREENBERG: I was just going to say for maybe future reference and it may well have been an issue of real estate, but I see this as a full back to back usually so I don’t want press releases to be longer than that, Jeff’s question on his issue might have been a little clearer if it had referenced, the press release had referenced that these were based on recommendations of the National Committee. There was no mention of the National Committee in the press release, and, I mean I know the recommendations were based on recommendations of the National Committee, they went a little farther in a few areas, but then the National Committee continues to serve as an advisory mechanism to CHI, so I think, that may not be in the press release but it should be recognized.

DR. COHN: Marjorie, thank you, I was actually going to comment, I made a similar comment via email to Dr. Lumpkin. But obviously I also sort of recognize that I think that’s part of the role of an advisory committee, is to provide expertise but also not be, be back there providing expertise, it doesn’t necessarily have to be noted in a press release.

MS. GREENBERG: No, but I think that does demonstrate that it wasn’t just the government kind of doing its own thing, that this was based on hearings that the industry participated in.

MR. SCANLON: There’s actually, I mean there’s internal paperwork that actually goes into all of this obviously but, and in terms of the adoption of the policy, but what gets into a press release is just, a lot of folks get to say what goes in and what doesn’t go into a press release, but I think everyone knows that these were the Committee recommendations. In fact, I’ve seen other non-governmental organizations sending out news about how happy they were with the adoption of the standards and they made it sound like it was their idea, too, and it was their initiative, so success has many parents and failure has a few.

MS. GREENBERG: I guess the best thing is when everyone adopts the Committee’s recommendations and thinks they’re their own.

DR. COHN: That may be the best outcome. Michael?

DR. FITZMAURICE: As Marjorie said, it’s clear that the NCVHS recommendations played an important part in this, it is one of the links between the private sector and the Secretary’s decision, and the many hearings that NCVHS has had and the recommendations that NCVHS made gave a lot of comfort and guidance to the Secretary on what is the right thing to do, and he weighed it and decided that this was the right thing to do. So we can be proud of marshaling public opinion and bringing it to the attention of the Secretary, and then the Secretary announced it in as many lines as he could fit on both sides of one page.

DR. COHN: Anything else on the HIPAA update? Ok, with that why don’t we move to our first, I guess our first discussion, I’m not sure I consider this to be panel per se.

DR. FITZMAURICE: Could I ask Karen a question? Karen, you mentioned the national provider identifier, do you have any sense of when the national health plan identifier will be out in the proposed form?

MS. TRUDEL: Probably at least a month after the provider.

DR. COHN: Any other questions? Ok, why don’t we move to --

Agenda Item: Update on WEDI Industry Activities - Dr. Jones, Dr. Schuping, & Dr. Lazarus

DR. SCHUPING: I want to thank you for inviting us back to continue our dialogues on two important projects that we’re working on. I just want to make a couple of initial introductory remarks. We had two tasks we were going to be giving you a briefing on today. Both of the tasks are still in the formative stages of strategies and the ideas that were working our way through. One is a pass through on renewing the regulatory process and the other is a pass through that was formed by our Board for contingency planning purposes. The recommendations or the ideas that the pass throughs have at this point in time I just wanted you to know that nothing has been brought to the WEDI Board or has been approved by the WEDI Board at this point in time which is why we don’t have anything official in the way of handouts for you.

The first task group is the task group on the regulatory process and as I think we explained to you on our last visit, this is made up of quite a good cross section of industry representation. We have representation from each of the standards groups, we have representation on CMS and OCR, and we have representation on the stakeholder groups, namely providers, payers, clearinghouses, etc., so that we’re getting a lot of good input from folks that are on that task group.

Secondly, relative to the contingency plan of, Dr. Zubeldia made reference to our picking off one of his attorneys, actually we have used Mr. Marks on a number of occasions, we were aware that Claredi had retained him to do a study, we invited his participation in our task group deliberations because there were a couple issues that quite frankly we did not feel we had a handle on and we needed his expertise, so we were happy to have that but I just wanted to clarify that.

With that in mind, Steve Lazarus is going to start by giving you an overview of the discussions that we’ve had to date in the pass through deliberatory process and then --

DR. LAZARUS: Thank you, Jim. I’m Steve Lazarus and this is a work in process as Jim has described. The group continues to work on the issue of, we’ll call it regulatory reform for lack of a better expression for now, regulatory process changes, and I might add that from the outset that process we’re looking at by this committee is more than what we might normally consider as the regulatory process. It starts from either something happening, submitted a question or an issue to the DSMO’s for the transactions, or something happened in one of the X-12 and/or NCPDP work groups to cause something to change, or a business issue that’s raised by WEDI and sent to one of these organizations as a way of initiating a process which doesn’t wind up in the formal regulatory process until there’s balloting by those organizations or recommendation from the DSMO’s to the Department, CMS to make a change. And then the regulatory process that we normally think about it would commence, so this is a much longer process, it starts before CMS or anyone else gets involved formally in doing something with the recommendation of the industry. And the issue that started all this discussion is it can take three years or longer from the time an issue is raised until we have a final rule in the federal register that describes how we’re going to deal with that issue and then another six months to two years to implement it after that. This is viewed as being too long a process.

The part of the consistency that still pervades in the committee’s thinking is that we have a number of public input and review opportunities that occur through this process, some of which are part of the regulatory process, some of which start before that. And it may be there are too many opportunities, maybe one of the ways of shortening this is to have less than five opportunities, or less than four opportunities for public input. And that’s one of the things they’re looking at in trying to formulate recommendations.

So that’s the major underlying thrust is we’re looking at the whole process, not just what happens once something gets started to be evaluated by the federal government as a regulation change. And we’re also focusing on there’s still consensus that the maintenance issues may be easier to deal with than the major changes or new regulations, so there’s some focus on how to deal with making this perhaps easier. And I think there’s more consensus about what might be done there but we don’t have anything to report on what that consensus is yet, so we’re looking at that as a separate piece, which may be formed first and what can be done with, particularly if there’s some types of maintenance issues that can be either totally eliminated from the process or maybe only have one version or review and to instead of having three or four to shorten it up, I think that, and most of this is based on the transactions effort to date, I think that’s because what we have the most experience with. I think this Committee will probably look at whether this all applies to security, privacy and other regulatory processes under HIPAA as well as part of their deliberation.

That’s kind of where we are. We do anticipate that they’ll be reporting to the WEDI Board which will work on this over the next month or two and come out with a recommendation. We don’t have a firm timeframe but what I would guess by early summer at the latest to move forward.

DR. COHN: I guess I need some help. I’d love to talk about this but I just want to make sure, is Steve going to talk about this and then Ed you’re going to talk about the contingency? oh, ok, so maybe we should just have a discussion about all of this for a couple of minutes and then we can move on to contingency planning if that’s ok. I know I have a comment or two but probably others maybe want to address this one. Kepa, do you want to start?

DR. ZUBELDIA: In culling down the number of times there’s a public review period or the length of the public review periods and so on, are you looking into not just the regulatory process but also the X-12 process or the standards development process? Are you looking at both or just the regulatory side?

DR. LAZARUS: As I said, we’re looking at the end to end process, so we look at the number of times there’s been a review, we include everything, and the committee will make some recommendations as to what pieces might be shortened or eliminated because they’re redundant. We don’t have anything to report out whether that should be changes in the X-12 process or the regulatory process at this point but we’re looking at everything.

DR. COHN: I guess I want to pipe in here. First of all I want to congratulate you, I think this is a very good way of thinking about it. I know when we had heard I guess an earlier report on thoughts in this area somehow even though the recommendations sort of around streamlining the regulatory process sounded on their face to be very reasonable recommendations trying to really turn them into something that could actually be recommended became very problematic, and as you notice we didn’t come forward with any recommendations as a result of that earlier conversation. Certainly I think it makes sense to look at it from the beginning to the end and see where in all of that it can be streamlined.

I think from my view I guess I would sort of, my hierarchy of sort of wishes in this area, and I think I just speak personally, is first of all that whatever recommendations come out, it would be desirable if they didn’t require legislative changes. It would also probably be on a second order if they didn’t require major regulatory changes, in other words that there were just ways by just sort of, you know in normal business if we were able to make the whole process more responsive. I don’t even know that that’s streamlining but I think we’re really talking about just making it more responsive, making things more timely in terms of coming up with responses to industry needs.

Anyway, once again, I don’t think there’s a Committee vote on this particular issue but I think that certainly the less overhead we can sort of put into the process of making this better that I think would be a desirable attribute of this, whatever recommendations come out. Are there any pieces that you’ve sort of established as sort of preferences one way or another as you move forward?

DR. LAZARUS: I think the only thing we can fairly report to the Committee at this time is that to the extent its possible in the recommendations we’d like to try to remove some of the steps from the regulatory process or minimize the regulatory part of the process. And the maintenance seems to be the most logical candidate for that, it doesn’t mean we can do it, but that’s where we’re focusing first in the deliberations.

DR. COHN: Let me just ask, do you have a crisp definition of maintenance?

DR. LAZARUS: No, part of the issue is to come up with a definition.

DR. COHN: That was part of the problem we had in our last discussion, too.

DR. LAZARUS: We’re working on that.

MS. BEBEE: Steve, I have a two pronged question. First, did I understand you right in hearing that you’re focusing on transactions and that would be your recommendation in summer of 2003? And the second part of this, if you’re extending out to privacy and security like you said, is there a project plan with a timeframe as to when you will be having something final, recommending for that?

DR. LAZARUS: The answer to your second question is there’s no fixed timeframe. What I said was that the focus has been on the transactions because it’s what we’ve worked with the most and understand the full process, and we’ve got more opportunities for formal public input through the beginning to end process, which part of which seems to be slowing it down, not streamlining it. We welcome the opportunity for input from the public but there may be too many times. We don’t have as many opportunities in the security and privacy arena because we don’t have the standards organizations working as a front end and we don’t have a DSMO process in place for those either. So it’s a different process and so we’ve been focusing on this transaction piece. And I’ve forgotten what your question is. And we’re hopeful that by early summer we would have at least some recommendations to make on these issues but again we’ll have to see how the committee deliberations go and how it gets processed through the Board.

DR. SCHUPING: I want to just build a little bit on Kepa’s question, and if there are situations that lend themselves to the money we currently use, avoiding duplicity where there is duplicity, and kind of tightening up that whole process of what can or can’t be done in that regard.

The other comment I wanted to make was we had also asked the Department if we could get some clarification beforehand in terms of what kinds of recommendations might or might not be possible without legislative activity, and the feedback that we got which we thought was acceptable and good to pursue was that it’s better for us to go ahead and formulate our recommendations and then submit them to the Department, and Department counsel will tell us at that point whether this is one that can be moved ahead without Congressional action or without some other type of action or is it something that we literally can do through cooperation between industry and the government. If you’ll recall, we were trying to get clarification on that on the front end and that was the feedback that came back to us, and we think it’s well taken. So we will do that as we shape each recommendation, they will have a chance to look at it and give us some guidance as to what it will require to make that a reality.

DR. COHN: Comments, questions? No? Ok, sort of keep us informed as you begin to move forward. I think our next Subcommittee will be at the end of May, it sounds like that may be a little bit before you come up with your recommendations, but certainly if there are recommendations you have to bring forward we’d certainly be happy to hear them at that point and that would reflect I’m sure in whatever we could bring forward to the full Committee in June. In one sense the timing of this is maybe a little less critical than the next issue, only because we really do need to be focused primarily on the initial implementation, but we obviously do want to keep track of this.

DR. SCHUPING: Right now while we don’t have a specific timeline for the task group on regulatory process, our objective with the contingency planning work, which Ed will addressing here momentarily, we really feel a sense of urgency here in trying to get our report through the Board and getting it into the Department’s hands I would hope by late April. And the objective there is so that the Secretary then has an opportunity to get out whatever recommendations they may decide to make, hopefully would be out to the industry by June 1, if not before, it’s not ideal but at least it gives a realistic chance for the industry to respond if there are going to be any recommendations coming from the Department, anything later than June we just thought would be really tough to deal with. So that’s the timeframe we’re on as far as contingency planning.

DR. COHN: Well it sounds like we’re transitioning to the next topic, which is contingency planning.

DR. JONES: I want to give you a brief description of what we’re doing on the contingency planning group. We’re actually spending a quite a bit of time on this effort, and just as an aside yesterday I was in a EMAC(?) Commission meeting and not even on the agenda, this issue of contingency with regard to the October 16 date, and not having everyone compliance, it ended up being a two hour conversation.

Our board comprises 31 members, it’s very representative, we have government representatives, standards organizations, providers, and payers, and as I said, this is a matter of great concern. There’s one common denominator, though, when we have these discussions, and that is everyone who speaks indicates that they’re going to be compliant and they’re worried about everyone else who they’re dealing with as trading partners. So one way to visualize this whether you’re a payer or a provider is look at a node and there are a lot of trading partners going off and they’re worried about those trading partners and the transactions that are going to flow.

Some of the contingencies from the health plan side, the payer side, that providers who are submitting electronically today and non-standard formats or content and who are not going to be compliant by October 16, those will be sent to the health plans and then the burden is on them to try and decide what to do with them. Their worry amongst others is this is going to create a large cash flow problem for the providers, and the recourse for the providers is to not submit those non-standard transactions but to revert to paper and then the health plans are worried about being buried under an avalanche of paper.

In the discussions that we’ve had on this we’ve come up with estimates all over the place that you might have anywhere from five to 50 percent non-compliance when we get to October 16th. I don’t think anyone knows what the extent of this is going to be, several analyses that we’ve done preliminarily indicate, even if it were as small as five percent, it could cause a significant cash flow problem, and these are some of the issues the board is wrestling with, the task group that we have in refining these.

What we’d like to do and we’ve referenced Richard Marks working with us, looking at legal alternatives, what we’re in the process of doing is trying to identify on the health plan side and on the provider side the various contingencies that each is likely to face, and then of course you have the vendor since a lot of these providers are using vendors, whether they’re going to be ready or not, and you have the testing issues. But what we’re trying to identify on each side are the contingencies that likely might occur, maybe five to ten of those on each side, and once we’ve identified those, try and make some sense out of them, see what types of solution given the constraints of the regulations are, and then to come forward with recommendations to NCVHS and the Secretary that would fall into three areas. The first would be what could the industry do within the existing rules. Secondly, what might need to be done that would be consistent with the Secretary’s existing authorities. And then what might be done if you needed additional statutory authority.

WEDI’s role, again, if you look at any one of the members of the board in the private sector, they’re going to take a particular corporate legal approach to their compliance in dealing with their business associates and trading partners. What we want to do as WEDI is try and come up with a consensus of what makes sense and then make those as recommendations. As Jim said, this is a very high priority, everyone on our board believes that we need to get recommendations forward no later than June 1st so that contingency issues can be addressed.

DR. COHN: Well let me start out with a question here, because I do know that certainly, you start out with a, from the interesting comment that of course no one that we know of, none of us would of course be non-compliant, must be somebody else. But having said that, clearly what I’m hearing so far is discussions mostly around the issue of a provider being non-compliant. Now what happens when the payer is unable to comply? Is that being considered as part of all of this?

DR. SCHUPING: That’s being considered as well. I think the greatest concern is of the health plans at this point. They’re receiving a number of electronic transactions, some of which meet the standards and many which don’t, and given the short time duration they’re worried what they do in terms of receipt. Do they send them back, do they come up with a trading partner agreement, this is one of the recommendations, there maybe other existing federal law or there may be state constraints on claims payment timeframes for example that may be affected here.

On the provider side, they of course have the option to send paper or electronic. I do know from other experiences outside of the WEDI orbit, mainly in the self funded industry, there are a number of TPA’s who are handling a very large proportion of transactions in the health care industry who are very late getting into this, and I think that arena may be a problem on the health plan side. We’re exploring all of these issues and I think the best service that WEDI can bring to this is to identify the areas, I mean some of the comments that come up are extraordinarily detailed and we’re not looking at that. What we’re trying to look at are kind of broader context where there are problems that we might be able to suggest areas of addressing.

MR. SCANLON: What role do you see the clearinghouses playing in terms of assisting with compliance, particularly the provider community who rely on vendors anyway? Is the ability to take whatever form the claims are in from providers and convent them into HIPAA compliant claims, isn’t that normally the role of a clearinghouse? Would they play an extra role here or it won’t change?

MR. JONES: I think there’s a great opportunity for the clearinghouse, particularly in the business associate context with providers to facilitating a lot of that. And again, that could be a recommendation. I think the industry is moving in, I mean this is a large industry, it’s very dynamic, it’s fragmented, and I think if that were say one of the recommendations, that it have some authority behind it, or recommendation as a possible solution, coming from the government might have much more impact on the provider side.

DR. LAZARUS: This is Steve Lazarus, I’m going to add to that. For the health plan or the TPA that is not ready, a clearinghouse may be a very viable option for the claims, they take the standard transaction and convert it into a proprietary or paper format for that entity. It doesn’t help them necessarily get all the other transactions in place but it would keep the cash flow and payment process going.

On the other hand, because there are new variables or changes in variables required in the claim, and those have to be provided by the provider, there may be less of an opportunity for providers to invoke the use of a clearinghouse. Yet they are not, electronic transaction and reformat into a standard with missing data elements. So it may not be a complete solution for everyone but it may have more of an opportunity on the payer side with regard to this claims transactions and not the others. But again, these are things we’re looking at as possibilities and will be included in the report.

DR. FITZMAURICE: Do the providers realize, and perhaps they don’t from your discussions, that after October 16th 2003 they are required to submit claims to the Medicare program electronically, and then that just qualifies them as a HIPAA covered entity. That was in the Administrative Simplification Act. Now that’s true for all but small providers. That doesn’t seem to be a very big out.

DR. LAZARUS: We and CMS and others have been sending that message out.

DR. FITZMAURICE: So you’re just reporting on what the industry is saying, not that this is what you advocate.

DR. LAZARUS: As we said, we don’t know what the percentage is who will not be ready on time, and we’re trying to measure that periodically through who’s doing testing. But of course the real issue is who’s in production on October 15th, not who’s testing on May 1st. But we get some indicator of who’s successfully testing at that point from some of the health plans, but part of this is people waiting for their upgrades from their vendors, or even ordering their upgrades from their vendors which may have been available, so we just have to wait and see, it’s hard to tell.

DR. FITZMAURICE: The other sense is that in the critical path toward providers becoming compliant with HIPAA transactions and codes that the vendors play role there, and that if the providers are waiting, they’re waiting for the vendors to give them a solution rather trying to reconfigure their office systems to submit HIPAA compliant forms.

DR. LAZARUS: Putting on my consultant hat for a minute, most of the providers have required upgrades from their practice management or hospital patient accounting systems to capture these new data elements and/or reformat, sometimes using the clearinghouse to format the data.

DR. FITZMAURICE: And are they happy with the responses from the vendors for these requests? Maybe happy is not the right word. Are they getting rapid responses to their requests?

DR. LAZARUS: I don’t know if we’d characterize them as rapid because a lot of the vendors and providers waited until the addenda was published before they went through this process so they didn’t have to go through it twice. And so we’re just experiencing this month delivery of upgrades that are consistent with that addenda. So we don’t have enough information yet to really know.

DR. FITZMAURICE: Thank you.

DR. JONES: I might add that I have noted for the first time in a long time, and I’ve been traveling quite a bit the last ten days, almost every day in newspapers there have been articles on HIPAA, and this is the first time that I’ve seen this with kind of some consistency. Now they’re focusing on privacy but at least it’s focusing on HIPAA. So I think what we’ll see is a curve, particularly after the testing deadline, I think they’ll be a lot more interest in this and there will be a flurry, just as there was before Y2K, of concern and worry. But I think we still need to deal with the contingency issue, because a number of people are convinced that even if its only a small portion, that could be very disruptive.

DR. LAZARUS: Michael, in response to your comments also, I think that having a date for testing in April made people very aware at this point in time they need to do something now as opposed to waiting until October, for those who understand they have to make a change. Which is now a growing percentage, so we do see a sense of urgency immediately as opposed to its not just an October issue, we’ve got to start this testing process.

DR. FITZMAURICE: That’s good to hear.

DR. ZUBELDIA: Ed, you mentioned that there is a large number of trading partners that think that they will be ready but their trading partners will not be. Is there a way to separate the anecdotal side from the true side? Is there a way to quantify how big the problem is and who’s going to be ready, who’s not going to be ready, some statistics or counts? And perhaps even some idea of the new data elements that Steve mentioned that are not present and you need them to send the transactions, how many transactions are affected by that? Is there a measurement that WEDI could do to identify the extent of the problem?

DR. JONES: I think we’ll try to address that, your first issue, this is an interesting comment, because one of the EMAC commissioners who’s also a WEDI Board member with a very large company, I don’t want to say what it is at the moment, they are going to provide an analysis of all of their client base, which is pretty extensive, in terms of implementation and compliance. We’re supposed to get that in about a week or so, and then they’re going to do that on an ongoing basis. The good news from them yesterday was in terms of their latest survey, they have about 90 percent of their trading partners who are either compliant or testing the transactions, and that had grown fairly significantly over the last couple of months. But I think given the makeup of our Board, both on the provider and on the health plan side, we can come up with some measure of that where it would not disclose any proprietary information but we could get a snapshot of what’s going on.

In terms of the data elements and so forth, I think that would be, that’s really a categorization issue and we could identify those.

DR. LAZARUS: Another source of readiness information which we’re making public is WEDI, together with CAQH, in January launched a new website which provides health plans the opportunities to voluntarily put up on their website their dates of testing and production for each of the transactions, encouraging all health plans including Medicare and Medicaid to participate voluntarily in submitting that data. And as of last week there were 25 health plans had put of their information for the X-12 and transactions and three had submitted their data for the NCPDP transaction. And that’s available free of charge on the WEDI SNIP website, hopefully it will grow so one could in a few months perhaps assess for those willing to disclose the dates, of testing and production on the health plan side, what kind of state the country’s in from health plan readiness.

We’re about to launch a similar effort on clearinghouse readiness, with a similar matrix in cooperation with a few other organizations to get that launched soon also.

MR. SCANLON: This relates to the sort of differentiating what kind of non-compliance is arising, and do you sort of suggest that there will be, well, I guess we’re just guessing, that there may be a greater capacity to transmit the X-12 and transactions, particularly the claims, but it may be that the data items would be an issue of non-compliance more so than just transmitting the X-12 in. Is that the sense you’re getting or we just don’t have numbers yet? In other words, to what extent is not having all the data items a source of a large proportion of non-compliant transactions versus other more basic sources of non-compliance?

DR. LAZARUS: The answer is we don’t know. Some of the health plans don’t require those new data items to adjudicate a claim, so the question becomes whether that could be processed even though it’s not a complete data set.

DR. ZUBELDIA: I would like to see if WEDI can explore this concept. Today the claims are being paid mostly or denied or adjusted, they’re being processed by the payers. And the system is not perfect, there is a good number of claims that have to be sent on paper because they can’t be processed electronically. There’s a number of claims that are sent electronically and they bounce against the different filters, either a clearinghouse filter or front end filter that causes the claim to bounce. And the industry is working with the imperfection. Some of the clearinghouses will put a provider into production if 95 percent or more of the claims are clean, knowing that there is always going to be some imperfection. Are we trying to set the bar too high under HIPAA? Are we trying to require perfection or is the system going to continue working with imperfection? Are you looking to that as contingency? Perhaps all we need to do is lower the bar a little bit and we still have 95 percent perfect claims, the industry could work with 90 percent perfect claims, I’m getting the impression that a lot of people are being scared by HIPAA and are saying it’s either HIPAA perfect or it’s not, and if it’s not I don’t want it. Are you looking to that possibility?

DR. JONES: I think that will certainly be an issue that we bring forward in terms of a recommendation, and there are a number of reasons for that. I agree with you, I think there is an unmeasurable gap between HIPAA perfect and HIPAA light if you will, but I also think it’s a time issue. It’s a very complex industry, it’s fragmented, I mean $1.5 trillion dollars, the large sector in the U.S. economy, we know from other sectors that have used these types of electronic processes and supply chain and so forth that it can work very efficiently at a very high level. I think we’re going from kind of 19th century to 21st century in a very large industry, a lot of people have dealt with paper and now they’re forced to, if they want to be efficient, really deal with electronic processes. I think it’s also an age factor, I think from what I’ve seen a number of younger providers are embracing this, so I think it’s a combination of factors. But there is that gap in there between HIPAA perfect and HIPAA light and we’ll probably get close to that bottom threshold and over time move up in that.

DR. COHN: I guess I have to figure out which age I am in terms of all of this, good to know that I’m young actually.

I guess the one question I have in all of this stuff and I actually think it’s very important that you do contingency planning but as I reflect on who the members of WEDI are or who are likely to put their training schedule on a WEDI website, of course these are people who know about HIPAA, who clearly are going to meet the training deadlines because otherwise you probably wouldn’t put them on a website publicly for others to see. I guess one question I’d have for you in terms of outreach to others who are not members of WEDI who maybe are just realizing now that there really is a HIPAA deadline coming up, and I think this applies to both, certainly applies to providers as we have seen, may apply to some of the payers. So I guess the question is, I know CMS is trying to get out there and doing outreach and trying to get everybody moving forward, what is WEDI doing in terms of that, and especially, and this reflects obviously on contingency planning of their amount.

DR. SCHUPING: Good question. WEDI as you know, through its SNIP initiative, has rapidly developed over I’d say the last year and a half, I think we’re at 30 or 31 now, regional affiliates that are located around the country. A number of them are also within the ten CMS regions, and their charge, or one of their charges, is to deliver information and education programs into those local communities. We’ve been rather pleased with the success that they are having over this past year in terms of the numbers of providers, small hospitals and so forth that they are convening, some of them have been up as high as 350 or 400 people coming out for like a one day program, which is a combination of HIPAA 101 and then maybe advancing a little bit depending on the audience. We also completed in December, as I think we reported at our last meeting, a joint pilot program with CMS. We conducted a program in Nebraska and one in South Dakota. And our initial feedback on that was very, very well received also, and again, they got some good handout materials, some good reference things that they could follow through on. So in terms of trying to get the word out through our existing regional entities and by collaborating with organizations like CMS, that’s the major thrust that we have right now.

In addition, we have a number of white papers, and other reports that are published on the WEDI and WEDI SNIP websites, and we are getting just thousands of hits on that every month. People coming in, they’re all free, people can come in and download the documents, and we’ve gotten a lot of really nice feedback on the value of those documents. People take them and then disseminate them to the people in their communities or they might put them in a publication and so forth and all we ask them to do is just reference the source of the information.

So we have that going on, and most recently, and this is in the privacy area, we had a very successful program in collaboration with OCR, we conducted a one day privacy workshop, the faculty was all department staff, and it was in the Chicago area, we had 1200 people came out on a Sunday to participate in this program. They were sitting around the edges of the floor and standing, I mean we had to turn away over 200 people because of the fire codes in the room that we had the meeting in. So that gives you an idea of the interest that’s out there and I think if you can just get the information to them through education vehicles or through handouts or we’re going to have a videotape which will be released in about a week or a week and a half on the OCR program, which will further disseminate that type of thing and I know CMS has been doing the same through their program. So that’s what we’re doing in terms of trying to get the word out and we anticipate continuing to do that in the months ahead, to the extent of our resources and capabilities.

DR. LAZARUS: You might add one other thing, on the health plan side, because of this recent collaboration with CAQH and setting up this website, we’ve obtained the endorsement of all of the major trade associations that health plans belong to to support their membership, encourage them to participate in submitting their data on the website, so it will raise awareness for the health plans as well to report publicly what their readiness is. I think as in the past WEDI is constantly seeking out to collaborate with others where it makes sense to spread the word further and bring collaboration together throughout the industry.

DR. JONES: Let me mention two other items. One is the WEDI Foundation. I had dinner last Friday with Lewis Sullivan to talk about a variety of issues and one of those was he is a trustee with the WEDI Foundation and we were talking about outreach in very broad context but in very specific context in terms of reaching, and this is one of Claude Allen’s goals when we met with him last year, to reaching African American and Hispanic and rural and under served communities about HIPAA, and going to some of the corporate boards that he’s involved with to get funding to facilitate that effort for WEDI.

I might also add, I’ve just finished a book for the AMA called HIPAA Plain and Simple that Dr. Sullivan’s going to do the forward for, and the AMA is going to get this, do a fairly aggressive marketing to the provider community to get this out and that will be out in the next couple of months.

So I think from all of these activities I think you’re going to see in the summer time, early summer, an escalation of outreach efforts. And I might add, we got the call less than a month before the Chicago National Conference on Privacy, and this was a Sunday afternoon, snowy as I recall, and 1200 people showed up which I think is really testament to the program that they’re doing on outreach and OCR and to the interest in the community.

DR. COHN: Certainly a good response, thank you. Questions? I guess I would, from my own part, it would be useful once you have your contingency planning recommendations if you would send us a copy as well, I’m sure that you’ll be sending them on to CMS but I think I would like to have the opportunity to look at them and sort of see what we think. I guess there is a careful balance here between providing enough flexibility in the industry to accommodate the transition as well as trying to avoid inhibiting people who are going to make their best efforts to try to implement. And we certainly don’t want to send any message to anyone in the industry that somehow this is not going to be a serious deadline on October 15, so this is an interesting set of recommendations that you’ve come up with.

Now are there any other questions, comments? Recognizing that our next presentation is in about ten minutes, why don’t we take a ten minute break, and that will just start up again with CHI. I want to thank you all very much, thank you.

[Brief break.]

DR. COHN: Let’s see if we can get started here. Ok, well our second session is really devoted to the Consolidated Healthcare Informatics Initiative, and obviously we want to thank Jared and Doug Odesky(?) and Cynthia Rourke(?) for coming and joining us. I mentioned this in our initial introductions this morning, but I want to obviously congratulate you on the formal announcement on Friday by the Secretary of your work. Obviously as I think everyone knows, the Secretary on Friday announced the first set of uniform clinical data standards for electronic exchange of clinical health information within the federal government. And I think Jared you’re going to be telling us some about that as well as sort of the plan directions for CHI. So, please.

Agenda Item: Consolidated Healthcare Informatics (CHI) Initiative - HHS Update - Ms. Adair

MS. ADAIR: Hi, I am Jared Adair, and I am very pleased to be here today to say to you that on Friday Secretary Thompson on behalf of himself as well as the Secretary of VA and DOD did make an announcement regarding the CHI. I am privileged today to be up here with Doug Odesky who has worked on this from the beginning with me as well as a new person that has joined our activity, Cynthia Rourke, I think Doug and I are very ecstatic that she has joined us. She has a health informatics background and I think will complement our work greatly, so I just wanted to introduce those folks.

I do sit here today representing the CHI Council. I may be a member of HHS but when I come to talk to you I really do come as the CHI Council, which involves VA, DOD, as well as other members of the Federal Health Care Enterprise. I wanted to share with you that I’m aware that Suzie did give you the press release, and we will see if we are able to also share the remarks that Secretary Thompson made on Friday at the Town Hall. As Suzie just indicated to me that when she read them she got goose bumps from taking a look at it for many reasons. I think one of them that made it so exciting for me is representing CHI is that it not only made the announcements about the specific standards that we were moving forward on that they were as Simon indicated for the federal government. But it did acknowledge that we believe we have a leadership role in standards and if Suzie liked that part of the speech I can only say she really would have enjoyed being in the audience as I was because the affirmation from the following speakers as well as people in the audience as they addressed Secretary Thompson was that they complimented him on taking this leadership role, they said it was the right thing to be doing, and one individual who is known to many of you actually proclaimed it as brilliant. So with that it was a very affirming day and where do you go from there.

So let’s talk just about what he did announce and if you would allow me, we did put out there five standards that we have adopted, we acknowledged that they were the first in a series, that we had identified a portfolio of 24 domains, and I think your handout reflect those domains, that we need to be addressing. It’s kind of like what we would consider our portfolio. I would hope to say, I wish I could say at least that when we finish those 24 domains that I would see our work done. I, however, being somewhat of a realist, realize that when we get to the 24 we will realize that there were things that we should have included and didn’t, and will always add onto it. But that’s ok, that’s ok. This is our first definition, our intent is as we identify additional things to add it, that’s our responsibility.

So we’ve announced five, we have already set up workgroups to take a look at the next six. And those workgroups are in varying stages. I would like to reiterate here something I have mentioned to you all previously. We readily admit that as our workgroups go off to identify what is the most appropriate standard for the federal government to be adopting in any one of these domains, we could have a series of results from that. First is that we find a mature standard that meets all of our needs and we just come forward, working with you all, and say this is the standard.

We could, however, find that there is either no standard for what we need, or that there is not a standard that is mature enough for us to be adopting. It may be, to use not a maybe eloquent term, lacking something. And that what we plan to do with those areas is to come back, with you, and to have that conversation. We would have liked to have adopted a standard in this domain, but after our analysis, after our research, we find that there’s either nothing or that this was the closest, and that we couldn’t in good conscious adopt because it was missing or needed or whatever. And that we hopefully would inspire, if you’ll allow me, the industry to go through a process to mature those standards so that we would find ourselves in a place to be able to adopt.

I don’t know, I probably took a rather long winded parenthetical phrase there on that, so if there are some questions please ask me know on that.

Ok, barring that I’ll move forward. Just to let you know that much of this information, if you want more information about CHI there is an eGov website, it’s eGov.gov, and it will have on there, I know it’s almost too easy after the other websites I do, eGog.gov, it will have up there kind of our progress to date. As you may remember we are one of the OMB sponsored eGov initiatives, so we have a responsibility in addition to report to many other places that we put our progress up there.

Other just to kind of let you know if that our teams are currently deployed to work on the six domains of medications, interventions/procedures, demographics, immunizations, lab result content, as well as clinical encounter. That’s what we’re currently working on.

Are there any questions for me, Doug or Cynthia since they’re up here with me about what the announcement was about, kind of how we broke things down into domains, or what the workgroups are working on now? I will be talking in a moment about some conversations I’ve had with Simon about how we could be working together, but I wanted to make sure before I went into that if there were any questions on the portfolio or the adoption of standards to date.

DR. ZUBELDIA: The first page of your handout has a bullet that is intriguing, the next to the last bullet says messaging standards connectivity. Are you going to be working on standard connectivity for this project? And is that something that could be used for the administrative transactions of HIPAA? Because as you probably know there’s a lack --

MS. ADAIR: Say it again. Say it again, because Steve is actually, Steve Steindel is one of the workgroup chairs, and now we’ve embarrassed him because he was having a sidebar conversation.

DR. ZUBELDIA: The next to the last bullet on the first page says messaging standards connectivity. My question is if you’re going to be developing a standard for connectivity that could also be used for the HIPAA administrative transactions, because as you know that’s one of the big problems is there is no standard connectivity for the administrative transactions either. So if there is something that can work for both, that would be great.

DR. STEINDEL: Well, the standard we specifically adopted was the IEEE standard that the NCVHS adopted, and we adopted it conditionally, the condition being that we’re looking at it as intra institutional at this point in time until it matures. And when it matures it might be able to be used inter institutional. But we did not look at a communications standard for administrative.

DR. ZUBELDIA: So are you looking at a communication standard for your transactions?

DR. STEINDEL: For HIPAA --

MS. ADAIR: No, no, no, for CHI, it does have interoperability.

DR. STEINDEL: Maybe down the road but not specifically at this time.

DR. COHN: Jared, maybe you ought to take a minute and just go through the ones that were adopted since there seems to be --

MS. ADAIR: Sure, Steve can do that in just a minute, see I gave him a moment to prepare himself. Kepa, I want to go back to two things you said there. The first thing is that just to be clear, if you use the word develop, I want to be very clear, we are not developing standards, we are in fact adopting standards and we are adopting standards that come from the industry, so I wanted to just, you may have used it as an interchangeable word but just for people who may not have heard of this before I wanted to be very clear on that.

The other is I want to go back to the premise of CHI, which is that as we adopt standards, we in the federal government will build those standards into our architecture. Our architecture govern our systems, and to a certain degree systems that we communicate with. We readily admit and are anxious for what Gary Cristofferson(?) would probably call the tipping influence, and that the private sector would want to adopt those standards. But I want to be very clear that as the CHI, as we come to closure on the standard, what it really “governs” are the federal systems, we as good business partners and we in leadership role will say to people what those standards are but it will be different than HIPAA which has a legislative mandate out there for the standards to be used across an entire industry. I just want to be very clear.

DR. ZUBELDIA: Thank you for the clarification, and I’m very aware of the adoption of the standards and that’s much better than creating --

MS. ADAIR: I knew that you knew, I just wanted to make sure.

DR. ZUBELDIA: One of the recommendations from NCVHS concerning this PMRI standards is exactly what you said in the second point, that’s to build enough critical mass by the government’s purchasing power, so the industry is kind of led in that direction by example and can voluntarily adopt the same standards that you’re adopting.

MS. ADAIR: I appreciate you using the term critical mass, usually they say weight, and I always begin to feel very guilty, and fat, so I appreciate the critical mass. Jeff, did you want Steve to first go through the standards that we have adopted or did you want to ask a question first?

MR. BLAIR: Jared, I just want a little clarification if you can. You just mentioned that these are different than HIPAA and I did notice that while the message format standards appear to be very similar to the ones that NCVHS recommended as HIPAA PMRI standards, that you used a slightly different name so I’m assuming that there is a purpose for that and maybe you could help us understand because I want to make sure that I don’t misrepresent what this means in terms of its similarity to the HIPAA PRMI standards.

MS. ADAIR: Sure. I will give it a shot, I may not be using all of the appropriate terms. To the HIPAA, what you referred to as the HIPAA PMRI standards, it is my understanding that through the HIPAA legislation that the NCVHS was requested to make recommendations to the Secretary as to what could be clinical activities, right? But there were, again, this is my understanding and it could be flawed, is that it did not, that those were recommendations going to the Secretary, that it was not like the administrative side of HIPAA where regulations would be promulgated for an industry to follow as it was on the administrative side.

MR. BLAIR: That is correct.

MS. ADAIR: And so we in the Consolidated Health Informatics project are very appreciative, as you take a look at what we did adopt the first round I think that you would see to the extent that we were appreciative of some of the research you did, and then we went back and looked at our own, the rest of the federal government needs. So what you all are doing in recommending is laying some groundwork as to kind of what the state of an industry is and that if somebody could wave a magic wand that that would be the standards that you all believed would be the appropriate one.

I do not know, and maybe I should, but I do not know once those recommendations were made to the Secretary kind of how all perceived that they would be effectuated into operation, I don’t now that. But I do know that we had an opportunity with a Consolidated Health Informatics project, the whole premise of the eGov projects are to think about how government could consolidate, or converge I think is the verb that they use, some activities that are going on. We had an opportunity that started with DOD, VA, HHS, critical mass certainly in the federal health care sector, and we’ve tried to bring together other departments that touch health care and come to terms with what we want to use. And by doing that, because we are a critical mass, it does impact I believe what the rest of the health care industry might want to do.

I probably have not answered your question very specifically but we view, in CHI, we view the work that NCVHS has done and is doing as a very critical piece of analytical work that is input into us that’s different, I mean on top of our ability to come and work with you to have conversations with the private sector even above that. So we view it as a wonderful piece of analytic work that we can work from, and as a matter of fact at the tail end of this talk to you about how we can maybe potentially line up some of our timelines to even get the domains that we see as the “next critical ones”, get information from you sooner rather than later, because my bosses, and had you been in Detroit or had you been in the Secretary’s office with me the night before Detroit, they’re very anxious to have this moved forward and I have to confess that sometimes it’s pretty difficult for me to explain why one doesn’t just go pick one, just like you were at a grocery store picking a box of cereal, that if you really didn’t like you could come back and buy another one next week. And they’re very anxious to have this moving forward whereas I try to explain we’re anxious and I know the NCVHS and others are anxious to have us move forward, but I think they’re anxious to have this moved forward correctly.

So that was a very long winded non-answer to you, Jeff. But Steve I have bought you time to think about what you would like to say. You owe me.

MR. SCANLON: Let me give a short answer before Steve starts. I think, Jeff, at the PMRI, the terminology that the NCVHS uses, the PMRI standards, and you basically refer to message format standards and vocabulary, clinical vocabulary standards, for various reasons we view the CHI initiative as a way to give legs to these recommendations and others in terms of messaging and vocabulary standards. For various reasons we changed the terminologies ourselves, we don’t call them PMRI standards in the context with this but they are consistent with, let me put it that way, highly consistent with the recommendations of the NCVHS. It’s just that this was the vehicle that we thought we could move some of these forward, and even that we added one. I mean we added one that is, again, consistent with your thinking, so it’s actually quite consistent with and it builds on the fine work of the NCVHS, and all of the work that preceded that in terms of identifying and recommending those.

DR. STEINDEL: To go into the specifics of what was adopted in a little bit more technical sense then what the Secretary has announced, basically we adopted the initial set of NCVHS recommendations. And we looked at them from a CHI and a time point of view, we need to realize that those recommendations were put in place and the profession is moving forward. So we did slightly modify them to meet some of our needs, but I don’t think any of these modifications would sit adversely with anybody on this Committee. The major recommendation was the adoption of your recommendation to use HL-7 for messaging. The modifications and your recommendation for HL-7 for messaging is specific to order entry, scheduling, medical record image management, patient administration, observation reporting, financial management, and patient care. And we adopted it in those areas as you did.

The subtle modifications that we made to it is your recommendation I believe goes, starts at version 2.2, we recommended starting at 2.3, so we moved it up. DOD has a little bit of a problem with that in they do a lot of messaging right now in version 2.2 but we did allow the Legacy systems to work with version 2.2. We also, because since the time NCVHS heard hearings XML has now become in flavor, we did say that we will accept both the XML form and the pipe delineated form of the version two messaging.

With regard to version three messaging, we did as you did except the statement that we hope HL-7 would move faster to version three messaging and I think we worded the statement a little bit more proactively than you did. We were very, we felt moving to version three messaging was very important. That is the major recommendation.

The secondary recommendations on messaging concerned the acceptance of NCPDP script, it turns out that from a federal government point of view there is not really that much transactions done with retail pharmacists. The Department of Defense does some but outside of that we could not identify much. But it was felt that NCPDP script, that we should go along with the industry standard, so that was accepted essentially unmodified from what NCVHS recommended.

The next two that we did recommend, we recommended somewhat in the same vein that you did, in that these are very important standards that we would like to see used more by the community. The first was the IEEE set of standards, that involved the interconnectivity of devices to electronic medical record systems. And like I mentioned in response to Kepa’s question, we took a hard look at these standards and we realized that there are instances that these might be used between, for inter institution transmission of information, somebody could connect a device up to a telehealth system for instance and be transmitting. We didn’t feel that the standards were mature enough to use outside of the control of a given institution no matter how broad that institution is, at least the institution in that environment could control things. So we recommended them for intra institutional use with the hope that they could be used in a broader sense and we’re envisioning in a broader sense areas like telehealth, we saw valuable growth into that area.

The last one was DIECOM, and again, it’s the same type of recommendation as the previous one, we recommended the use of DIECOM intra institutionally, we didn’t feel at this point in time DIECOM was mature enough for the entire institutional transmission of information. And some of this has to do with some of the subtle differences between the structured document report of DIECOM and the CDA report that HL-7 is developing. So that was another conditional recommendation.

Those are the recommendations in the area of messaging, and as you can see they follow generally the form and format of what the PMRI recommendations were with little twist that represent the particular needs and changes of time.

The last area that we made a recommendation in is an area that NCVHS hasn’t made a specific recommendation but we feel it will, it is a relatively non-controversial area in the profession. It is an area that both VA and DOD felt they needed a very strong statement so that they can move forward, and that recommendation was for the use of the laboratory portion of the LOINK code set for the identification of laboratory test names in messaging.

We did put a condition on that, and the condition was and Clem has, Clem McDonald in his position in Regenstrief and as head of the LOINK project, wholly supports this condition, and that is that vigorous efforts need to be made to clean up the structure of LOINK and to remove duplications and ambiguities that exist in it. As we know, LOINK has developed as an ad hoc system for a number of years and I think everybody in the profession is aware that we need to step back and take a look at it and make it a more robust system if we’re going to move it forward. So we did accept it under that condition, we’re going to be using it the way it exists today and working with Regenstrief to develop a more robust form of LOINK.

And those are the specific recommendations with probably as gory technical detail as really exists in the reports, the reports are much longer, but the essence of the gory technical details of what I described.

MS. ADAIR: Thank you, Steve. The last part that I wanted to kind of address today if you will allow me is kind of something that we’ve not had an opportunity to really talk through, but its how it is we could work together and the increasing need, especially now that announcements are publicly made, people know what we’re working on, at least for the private sector to have confidence in CHI, and understand what we’re doing and what we’re looking at and all those types of things. And I’ve been fortunate in that I’ve had some conversations with Simon and various shorter conversations admittedly with Jeff Blair about this just this morning. I think that we all recognize the need to kind of let the private sector know how we want to have those conversations and so Simon and Jeff are being most kind and we’re going to set up a session where we haven’t quite figured what the structure, we’re going to talk to Marjorie and some other people, but we haven’t quite figured out what the structure is going to be like but that would really allow us to put some thoughts that we in CHI or potentially NCVHS have out there, kind of let the private sector know what our position is, see what they think, and see if we can get to a place that meets everybody’s need.

I would like to, though, go on record that I do not believe that as we take a look at our workgroups that we feel that one size is going to fit all, and that it won’t be the same for every workgroup. Let me give you some examples of what I mean by that. I believe, maybe the LOINK Steve mentioned earlier was a good example of this, is that as we deploy a team, a workgroup to go look at a domain, they because of other work they’ve done, because of work that’s been done here or wherever, they pretty much know what the definition of that domain is, kind of like what needs to be included, where to draw the lines around it. And they also understand because they go to many meetings and are involved in many activities, what is the universe of standards that are out there in that field. And that they can basically say we really feel comfortable with moving forward on this one, and that they’ll do their analysis and that we would come back after their analysis and have a conversation here and in a public kind of forum to say this is what we looked at, this is just to let you know, this is where we kind of saw issues, and this is where our preliminary recommendation is, and if it has caveats, if it has, there was a different word you used, Steve, conditions, thank you, if it has conditions, that’s time, the forum to kind of put those out there for people to understand what they are. That’s kind of one approach that would work and I think will happen.

I think another one is is that without using names, we’ll deploy a team in one of the next domain, and the workgroup is going to go out there and they’re going to scratch their head a little bit. It’s going to be important, but it may not have the clear definition that others do, nor are the people who sit on the workgroup going to feel as comfortable that they truly understand what the universe of potential standards are in that area, and that they could come to the Council, and we could come to Simon, Jeff, and say help. Before we move down a path we would like to ask you to host something that would allow us to get information on the front end. And then we’ll go away, once we’ve gotten that information our workgroup will go away, it will take a look at ok, we got some great input from the private sector, here’s where we kind of now come out. And that we would hopefully then be able to come back again with the good grace of Jeff and Simon and say alright, here are our preliminary recommendations, by the way thank you for your research and analytic piece in the beginning, but as I take a look at it and I don’t know that I have completely though through every kind of scenario, but those are kind of the two extremes and why don’t necessarily believe one size is going to fit all. But I think that what we, we’ll go back and take a look, if we see there are others, but in a forum Jeff and Simon would host yet to be described how it would, we set up, is it a meeting, is it a conference call, we would like to put those kind of positions out and see if they work for people.

I continue to believe that all of us in the CHI Council, when we come forward with recommendations, don’t want to have, we want to have people’s reaction to be, well, of course you picked that one, that makes sense, we understand it, may not have been our first pick but we understand it. That’s our desire. The last thing we want to have happen is that when we’ve come to a decision on one, when we make a recommendation on one, to have people go well why did you do that. That’s not where we want to be, that’s not where we want to be. You may have different opinion, but at least we want people to say yes, I understand I it.

That’s kind of where we are, our request of Simon and Jeff was to hopefully set up that next forum where we could have kind of a process conversation with any of the Subcommittee members as well as some of the private sector, it’s that we’re talking and I guess this is very preliminary, so I’m not wanting to put Jeff, Marjorie, or Simon on the spot here, but we’re like talking in the mid April kind of time period, just to let you all know. And we felt it was important to not wait until, my understanding was the NCVHS meets next, as a whole, at the end May. We felt like that was too far out there, and wanted to do it sooner.

That’s what I had to say today. But it was a great week last week.

DR. COHN: Comments? Questions? I think I obviously I think speak for the Subcommittee where we will obviously do everything we can to help move the process forward. I guess I’m also hearing, even though not explicitly stated, but there’s I think an intent to get public input as these recommendations move forward before they become finalized by the government, even though they really are intended for government use.

MS. ADAIR: We are always anxious within, this is where I have to give all this caveat, within the appropriate channels and all those types of things, we are always anxious to get input, we are always through those appropriate channels anxious to let people know what it is we’re doing. They may not, I always have to number one apologize for my throat, but number two, that is not to say, and I think people know this, but I think it’s always important to say that in our recommendation and our adoption process we really are wanting to understand what the spectrum is out there, what people’s opinions are, but we really are adopting for the federal government and have to take a look. One of the things we’re very happy about though is that on our Council it’s reflective of people who provide care, who pay for care, who use the data, so that we believe we have a good cross section to be taking a look about what needs are, for which we’re very happy.

DR. HUFF: I just wanted to second the idea that the more communication we can have between others who are choosing standards and the CHI initiatives, that’s a good thing. And specifically it just has to do with the fact that as you know, DIECOM and ASTM and HL-7 and all those standards organizations are at the same time considering what terminology should be adopted for use in those standards, and I don’t see any discord in what is happening but there’s certainly the potential for that in the sense that those groups could choose something else than what CHI chooses and probably for all the right reasons, the more open communication we can have about that the better we’ll be, so that we don’t have mixed messages coming from the standards organization and a different message coming from the CHI work. And so I strongly support this opportunity through NCVHS to have open dialogue between the CHI activity and the standards groups.

MS. ADAIR: Thank you. The other thing we should mention is that at times if its appropriate, and I’ll probably say this in the wrong way, is that we may come to you all and say because our business needs, our business drivers, we’re establishing a certain priority within the domains that were deploying teams on, and we might say to you all we know you’re working on some things, is there a way, we might ask, is there a way you could reprioritize to be even greater assistance to us. We recognize that that might change some of your plans, but if we could at least have those conversations I think it would be helpful and I think that it would also be supportive if not consistent with what you just said.

DR. HUFF: The other thing that I ponder is there’s the adoption of standards at some high level, and then there’s another level that has to be considered as you put these things into use, so for instance you think about drug codes, there’s more than one context in which drug codes are used, so you can have one set, you may need one set of codes for drug ordering and a different set of codes to know what was dispensed to the patient, yet a different set of codes if you’re talking about what they’re allergic to because those tend to be class names whereas the other things become discreet holding your hand things, etc., etc. And that, through my experience in the standards, that’s where the big work is now, it’s to say what part of a given terminology should be used specifically in a given part of a message, and you can’t talk about it until you talk about the message structure and exactly where you’re going to use it. And again, that’s a part of the activity that I think we would want to stay tightly coupled so that we’re doing that in a uniform way between the standards organizations and all of the work the CHI is doing.

MS. ADAIR: There are, as you point out, there are numerous complementary activities going on, and that should we not be careful could be working against instead of for one another, and so we do come to you and asking you to help us with making them complementary as opposed to, there’s a better word for not working together but I think you got my message.

DR. HUFF: And I agree 100 percent. There’s no intent to do anything different than what anybody else is doing, but the organizations have their autonomy and so unless we’re careful it could happen, and that would be a bad outcome.

DR. COHN: Jared, what is your timing, do you have to go right now?

MS. ADAIR: I unfortunately, unbeknownst to me, right before I came up here have a budget meeting to go to, for the other side of my responsibilities. I apologize. I believe that Doug and Cynthia and Steve and others, Marjorie or Jim who sit on the Council will be here but I do need to leave.

DR. COHN: Ok, well we want to thank you obviously, we’re all excited by the progress being made here and obviously we stand ready to help and work with you, clearly there will need to be a couple of conversations between, over the next short while to figure out how that will be.

MS. ADAIR: And I from the CHI Council am very appreciative to the NCVHS as well as this Subcommittee to number one, be supportive, and number two, working with us so much, you’re not holding us to any kind of real rigid types of things, we’re very appreciative of that.

DR. COHN: Sure, Suzie?

MS. BEBEE: One area that I’m thinking that we could start working together right away is in preparation of the May meeting and Mike and I, and if this is ok Jeff, are working together to put together the questions for the three different panels, and Mike and I could circulate that to your group to get the input. We had talked about that last week, is that alright?

DR. FITZMAURICE: Good thought, Suzie.

MS. ADAIR: I’m going to go change my mindset to dollar signs now instead of --

DR. COHN: Steve or Doug, I guess we have a couple of overheads here that I thought might be useful, I don’t know who produced these --

PARTICIPANT: I actually put them together --

DR. COHN: Oh, did you? Because it occurs to me that we made it through slide one, we’ve never, we’ve really not gone through slide two, three, or four, and it might be useful for us to sort of hear, I mean part of the issue of making sure that we’re all helping each other has to do with sort of understanding a little better of what your priorities as well as timelines are for your workgroups and products. And now that it’s an official activity that you can all talk about we were sort of hoping that maybe you could sort of maybe explain to us a little bit about the teams and the outcomes anticipated as best you can. And I know Steve is, hopefully can join in and make comments as it goes through also.

MR. ODESKY: I can give an overview from the project management perspective. As an OMB sponsored initiative for eGovernment, one of the expectations that the President’s Management Agenda has is that we don’t do business as usual in a sense, if we take on a nation wide national initiative we do it in a very structured way with very specific milestones, goals, and so forth. So one of the things we worked very hard on in the first year was to get to a target portfolio, and that’s what these pages represent, as the 24 messaging standards, domains and vocabulary domains that our project has defined to OMB would have as the target that we’re after. It could very well at times change, I don’t see it in any way shrinking, I think it’s always on the table for it to grow. At the same time OMB does have expectations that we’re not an endless federal undertaking, that we have a meaningful target and meaningful closure on what we’re after with them. It does not mean that part of our objective would be to establish a, in change management in the government to establish a way to let this activity continue for the long term. It’s just that in the portfolio of eGovernment projects we need to have a defined start and end point. They recognize that its an ongoing process for the whole government to tackle this, beyond their work.

I think as the teams take on the, where we deployed, on page two, we have six teams out there in the field right now, we have about 30 subject matter experts on the teams, the structure of each team is to have a team lead, with Cynthia joining the project we now have an expert to help what I call harmonize the teams work. Up until now we’ve had that as a gap and we recognized we needed to have someone there to recognize those types of, to strengthen what comes out of their work in that area.

I think the next stages, I think we’re going to be having results come in in a staggered way now, where you’re going to find as Jared was describing, some teams will have solutions that come more readily than others, so we will most likely have the new domains deploying teams in a staggered fashion. As one team reports in, recommendations come into the CHI Council, they may be recommendations that we needed to bring in to the NCVHS, that will take on the adoption mode while the subject matter expert resource that we had now has the ability to select from the remaining list of domains and tackle that domain and let that team get deployed. So we’ll have results coming forward in a more staggered fashion from this point on.

I’ll offer it up to Steve and to Cynthia to build on that.

DR. STEINDEL: I don’t know how much I can add to what Doug has said, I think it’s a very good description of what’s happening right now. To give you an idea about the staggered nature of this, I would say, and I’m not going to mention which ones, three of the teams that are current deployed are probably in the stage of writing the final reports and they will be submitted to Council over the next month period. And I think three of the other teams are in various stages of selecting terminology standards. And while I will not mention any teams names, I think we’re cognizant of what Stan said earlier about medications.

DR. FERRER: Steve, I’d also like to try, because I do sort of lead one of these teams and I want to apologize for the formalism but we do have to have a better mechanism because April 30th is the due date for the teams that are currently deployed, and to date, even though we have informally, Stan Huff, -- and the likes, we don’t have a good mechanism by which that formal intellectual guide, or guidance if you will, from the technical vocabulary terminology expert is really put in, so we’re going to come up with a product that will “be done by April 30th”, and then we’re going to “come to NCVHS to kind of re-look at that”. It seems to me that we have to really get into sort of an efficiency dialogue as to what the mechanism to do it because from the beginning of CHI we have been rather firm that we just haven’t been able to do that well and to date I’m not convinced that that process is being done well.

DR. STEINDEL: I think Jorge is quite correct on that, and I think with Cynthia joining the team we can start to figure out a way to streamline that process and get the information both to the teams and to the outside through NCVHS in a more efficient fashion. And I think as Doug pointed out, the type of time pressure the eGov project has put, OMB has put on all eGov project has kind of made this a seat of the pants management evolution and as we move further down the process we try to find ways, we understand where the barriers are coming into place and to streamline the process. And I think Cynthia sitting here is one example of that because when this project was originally conceived, Jared had Doug, and she had Doug for I think much longer than Doug would have liked, and then Jared eventually went to her administrator and said help, and got help. And this is very important to us and for us that are deploying in teams, that we now have more central office support and the ability to get things out in a more coordinated fashion.

The next set of teams, question?

MS. GREENBERG: It is clear, but I thought we should make it clearer that these teams include HHS representation and several agencies within HHS, but they aren’t all actually even chaired by HHS, they have strong representation from DOD and VA and I think at least a few of the teams are actually chaired by someone from DOD or VA, so it’s very much a cooperative activity of at least those three agencies. There are other agencies that are sort of following the work, but those three are very actively involved.

DR. STEINDEL: Yes, we even managed to pull USDA into one team, and one of the other teams is going to be deployed, I think we’re going to try to pull EPA into it. So we are trying, the standards that CHI adopts are federal wide standards, and CHI is attempting as much as possible to bring in all units of the government.

MR. ODESKY: Excuse me, this is Doug again, the process the teams go through is to first make sure the membership always has an HHS, a DOD, and a VA member, that’s in our charter. It may or may not have representatives, it does not need to have representatives from all other partners. And that structure, that government structure is that after the team defines their domain, the range of topics of that vocabulary that domain will address, they research and they make recommendations to the Council. At that point the entire Federal Health Enterprise is represented at the table by all the way down to agencies like United States Aid, Department of Treasury, State Department and so forth, have the ability to vet the recommendation in their own agency and bring it back to Council for the Council decision on government wide adoption.

DR. STEINDEL: Just to add to that structure, the actual workgroups do have the ability, since we recognize that the federal government may not have the expertise in all areas that they do have the ability to consult with outside experts on an individual basis to advise the team in these areas, and some have.

DR. COHN: Let me ask a sort of slightly separate, different question, because I think, obviously we’ll be also talking a lot about this, it sounds like whenever we have, whatever it is we do in April at this point which is still to be formed. You’ve chunked up things in I think a very appropriate way for work to be done, but obviously there are a number of sort of cross cutting strategic issues that both the government and private sector have, and one of them for example is patient safety. And I was just sort of curious about are you, is there some other process you’re using to make sure at the end of the day you have addressed those issues, or is it just part of every team charge? How are you approaching that?

DR. STEINDEL: In the specific area of patient safety we did recognize that as an important charge to CHI to look at in some fashion. And as you notice, it does cover multiple domains. What we did with CHI is we recognized that right now people are looking at patient safety in somewhat two broad areas, and one is medication related patient safety, and then the other areas. And what we did is we charged the medication group to look at patient safety from that point of view for medication errors, and the workgroup is appropriately staffed with people within the federal government who are involved in the patient safety movement. Now the other areas of patient safety, one area that we’ll be looking at is in the area of public health reporting, to make sure we get reports of patient safety, and that workgroup hasn’t been formed yet, so I can’t comment on what the makeup will be. And then finally there’s the devices group, where it’s going to be another area of patient safety, and that’s one that hasn’t been formulated yet either. So we are looking at those things.

MR. ODESKY: There also was a strategy that came into forming this portfolio of 24 domains to go after as defined within the CHI project, it does not mean that there are limits for the whole federal government forever. The idea was that we needed to go through the governance and adoption process for standards that had clear, very likely, lots of choices, strong choices, and the outcome would be one that would be in a sense easy to get to. We wanted ones that there weren’t as many choices and we would need to nudge and wrestle with the governance and the, how will the government stimulate the solutions to close the gaps, we needed some domains to deal with that way. And then we needed some domains to deal with where we projected that there would not be any easy choices, and perhaps no choice, and we needed to figure out, come out of the two years that CHI exists as an OMB sponsored project with models on how will the government in the long term deal with more domains down the road that fall into these boxes of challenges.

DR. COHN: Jeff, you had a question?

MR. BLAIR: In the press announcement on Friday, it referenced right at the start the National Health Information Infrastructure and how these standards would be part of a National Health Information Infrastructure and I was excited and very happy. Could you help me understand a little bit since that was referenced how do you envision that this is fitting in with a National Health Information Infrastructure, it sounds like you’re doing a lot of definition of what this should be, how does this mesh with activities within HHS on the National Health Information Infrastructure?

MR. ODESKY: I’m going to let Jim Scanlon --

MR. SCANLON: Jeff, I can, since we sort of put that terminology in the press release, let me. I think we are trying to get everyone to think of both our agencies and the health care community and the public health community, to think of these not only as standards but as a part of a larger vision and framework that we’re all aiming towards, and this is, the standards as you know are part of that framework, privacy and security policy is a part of that as well. Leadership and convening is part of that, and demonstrations and research and other search things are part of that as well. I think the intent here was to place the standards activity in that broader framework, not to just look at it as an isolated, again, I think a number of folks, it’s becoming clearer but a number of folks are kind of confused, not the industry and the aficionado so much as others, lay persons more or less. They really don’t understand how these things fit together. Standards somehow are going to, standards are necessary as you know but not sufficient and people are confusing sort of ends with means and what’s necessary and what’s efficient. So I think in most of, whenever we have a chance anymore I think HHS is going to try to place these various activities in the context of a full NHII vision so people will understand where privacy fits in, where standards fit in, where research fits in, where demos fit in, and leadership and convening type activities, where the work with the NCVHS fits in, and I think that was more or less a stake in the ground that says this is one part of the overall National Health Information Infrastructure, so we can begin to relate. Otherwise, as you can imagine, it’s quite confusing for folks who think you do standards and you’re finished, or you do privacy and you’re finished, and how do these relate. So I think that was the purpose, and all of this is conceived as contributors and elements of the NHII. And there will presumably be other announcements later that will again reference the NHII as the anchor but they will fit in in some other way. I hope that, it was nothing more complicated than that.

DR. COHN: Thank you. Once again, we’re delighted that all of this is happening and moving forward. I think the Subcommittee itself as it looks at its work plan and deadlines for the remainder of the year is probably going to have to put some thought into whether our deadlines are still appropriate or whether there will need to be some intermediate deliverables.

MR. ODESKY: And on behalf of Jared, I thank you again, I encourage folks to, again, to use the eGov.gov website on at least a monthly basis and I’ll be doing our best to try to push out our documents into that as an archive of our work. Thank you.

DR. COHN: Thank you so much. We ok with continuing at this point? We obviously took a break a little earlier. I think our next item for discussion is really the ASCA statistics, and I think Steve and Michael are taking the lead on that.

Agenda Item: Presentation of ASCA Statistics - Dr. Steindel and Dr. Fitzmaurice

DR. FITZMAURICE: As you know, ASCA when it was passed gave covered entities an option to extend mandatory HIPAA coverage for their transactions and code transmissions for a year. To do that they had to not only put forth a compliance, well they had to put forth a compliance plan that started testing on April the 15th, and submit information to a process to CMS, CMS was charged with setting up the process, and quickly came out with a model application form that most everybody used. They put it on the website, which was a benefit to us. You can see on the front that CMS or the department through CMS was charged with giving NCVHS a sample of these compliance plans for analysis. But the electronic submission worked out so well that we were able to get all half a million submissions in electronic form. I think there were about 30,000 to 50,000 that had to be converted from paper submissions to electronic forms. So we were dealing with a whole population, not just with a sample. We received it in February of 2003, the population was 548,644 responses. In accordance with ASCA, the identifying information was deleted to protect the confidentiality of the covered entities submitting reports.

As it turns out, 94 percent of the respondents were providers, an overwhelming majority. Health plans six and a half percent, clearinghouses one percent.

Congress charged us specifically with, us being NCVHS, to publish, regularly publish and widely disseminate to the public reports containing effective solutions to compliance problems identified in the plans analyzed. And we took some liberties as you’ll see with Steve’s presentation with making some assumptions that those who finished first must have had better processes. We also looked at the reported problems that they had, why they weren’t able to meet the October 16th, 2002, deadline. Many of them reported more than one, I think the average was about three.

So we did address the requirements of Congress to look at effective solutions to compliance problems, but I can’t say that we did a great job on the effective solutions because the plans didn’t contain effective solutions. They did contain the problems, so by inference we looked at what are the factors that influenced those who finished first. And Steve, let me turn it over to you to give the results that we came up with.

DR. STEINDEL: Thank you, Mike. What we’re seeing is very hot off the press, this slide presentation was put together this morning, but what we’re trying to do is just present the information that we found in the ASCA database that CMS provided to the Subcommittee, and what we first thought would be the significant information we could provide from that database.

As Mike mentioned in his introduction, basically everybody that commented, 90 percent were providers. There were a small percentage of clearinghouses, one percent, and about six and a half percent of health plans. There were a few responders that indicated they were multiple types, clearinghouses, health plans, and providers, and I am not going to try to make any comment about what type of entity that might be. I think a health plan provider might be a little bit closer, maybe the managed care organization would think of itself that way that’s doing it, but that I’m not sure about, we had no way of analyzing it.

For Jeff’s point of view, I’m sorry I couldn’t get this out in advance, but I will try to go through the numbers and make sure the people on the internet can hear it as well. Some people like pictures a little bit better and this is the same information we had in the table in pictorial form, and you can see the vast amount of providers that are there.

From a provider type point of view about 44 percent indicated they were physicians or groups practices. The next highest class did not classify themselves, they indicated they were other, and that was about a third of the people that were responding. In increasing, or decreasing percent, the next highest percent was dentists, at eight and a half, pharmacies at three and a half roughly, nursing homes at just under three percent, durable medical equipment suppliers at about two and a half percent, hospitals at about two percent, home health agencies a little bit over one and a half percent, and hospices at about half a percent. So that was our classification of the provider group. And again, for people who prefer pictures, this is what it looks like from that point of view. I know I see distributions easier as pictures, so I’m providing it both ways.

One of the key questions that --

DR. ZUBELDIA: Steve, a clarification, on your provider types the total is 415,000, and on --

DR. STEINDEL: There were a group that did not answer that question, and they were not all clearinghouses and health plans. In most of these tables there are some missing data. In general, I would say in virtually all of the questions there were some people that we did not get answers from.

MS. AULD: Steve, is there any indication of who falls into the other category?

DR. STEINDEL: I did not analyze it, actually the database does give demographic information for the people who did respond but in the timeframe we had we couldn’t analyze it. And from analyzing it you probably would have to guess, if they said South City Hospital and indicated they were other you’d probably have a good indication, but my suspicion is working with a lot of databases like this, the other category probably mirrors the distribution of people who did identify, but I can’t say that for certain because we did not look at it.

One of the things that the questionnaire was most concerned about were where are you in the process, and if you are asking for an extension what are your reasons for asking for the extension. There was a list of 12 reasons, people were allowed to select multiple reasons, the median number of reasons that were selected by a respondent was three. 90 percent of the respondents gave between two and seven reasons. And as you can see from this list, a few gave all 12 as a reason. A large number gave only one as a reason. So people were, there were multiple factors that they looked as reasons for delays.

The next gives the order, the rank order of the reasons for delays of the total population. What I’ve provided in the printed report, and I’m not going to go into in this handout, and this is also true for other areas, is I have provided tables and graphs of breakdowns of reasons for delays by the various entity types and provider types, so that those who wish to look at this in more detail can look at it and draw inferences. In general, there’s not much that can be drawn from the breakdown tables, but just from my cursory look at it I could see some interesting just observations that I might make, and this might be useful for targeted interventions. But the information is provided, again, I will not go into it.

The two main reasons for delay were waiting reasons, well there was implementation time was the first, they felt they didn’t have enough time to implement and that was true for about two thirds of the population. Waiting on the vendor, and they don’t give reasons why they’re waiting on the vendor it was just given as a class, was just under half the population. Again, about 45 percent of the population, just under half, was waiting for standards information. 41 percent of the population felt they needed testing time, and don’t forget they’re asking for this extension so we don’t know how this goes into the extension period, this is why they needed that extra year. They wanted clarification on the standards, that was just over one third of the population. They were waiting on their clearinghouse to do something, it didn’t say what, and again, that was about one third of the population.

Now we get into some of the things that are more locally oriented. Money was cited as a reason by just about 17 percent of the population. Hardware about 16 percent. Staff, 12 percent. Date requirements, which I’m not sure what it means but I gather it’s very similar to understanding what the standards are, nine percent. Other reasons, which we did get text for all the other reasons, I did not analyze the text, it was about eight percent, and one reason I didn’t analyze the text, you can imagine that eight percent of about 500,000 responses is still a lot of text to go through. Code set implementations about seven percent of the population was look at that.

We can look at some of these reasons for delays, waiting on clearinghouse, waiting on vendors, depend on others, and appear to be outside of the respondents control. Some can be, and in many cases have been since the start of the extension process, and we heard some presentation on that this morning, involves educational materials, clarification, standards information. The length of calendar time for implementation and testing appear to be a major reason why they were asking for extensions. Some of the times waiting for clearinghouses and waiting for vendors could be due where the clearinghouses and vendors haven given other reasons for it. Suzie?

MS. BEBEE: You know, it makes me think, too, Steve that Steve Lazarus was here and said that until the final addenda came out, that could play into this which would be good news.

DR. STEINDEL: And we do make that comment in our report, that some of this wait could have been done waiting on the final standard to come out involving the transactions, and we note that that standard did not come out until February 20th. So yes, but there was no way that that could be ascertained since this questionnaire was asked before the standard went into place.

One thing that we were interested in is that a lot of the reasons for delay, while it was a sizable percentage, were not internal, like money, staff, hardware. These were sizable percentages but were not the major reasons for delay.

The estimated cost was requested in terms of cost ranges. Again, the largest number of respondents, 35 percent, said they didn’t know. But of the people who gave cost ranges, 36 percent estimated their cost as under $10,000 dollars. In the range of $10,000 to $100,000 dollars, about 20 percent said they fell in that range. Between $100,000 and half a million, 5.1 percent. And between half a million and one million, just under two percent fell in that range. And 2.4 percent felt the cost was over, will be over a million dollars. And it’s interesting to look at the breakdown of the estimated of cost by provider type and entity type, because some of that, you can see where some of the larger numbers fall.

They asked about process steps, they defined what I called phase one, phase two, and phase three process steps. The first phase was awareness, are you aware of HIPAA and have you completed your awareness. The second was an operational phase, have you started implementing. And the final phase was testing, phase three, have you started and completed testing. What we have is shown now is the breakdown of people who have completed the various phases. 50 percent, just under 50 percent, indicated they had completed none of the phases at the time of asking for the extension. About 30 percent had completed phase one, which was the awareness phase. And then we get down to the later phases, it drops tremendously. As we’ll discuss in a minute, those people, only 3.4 percent of the population at this time had completed phase three, which was the testing phase. Now since the final standard wasn’t in place we don’t know if this is good or bad, but they had completed testing at phase three, but it’s only 3.7 percent of the population. And again, from a visual point of view for those who like graphs, this is what it breaks down as, and we can see the overwhelming number of people who are either have not started even the awareness phase at the time of the extension process or are just starting the awareness phase. Jeff, a question?

MR. BLAIR: Yes. The 3.7 percent that really were quite far along, is there a match, maybe you’re showing it now, I don’t know, was there a match to provider type, like for example --

DR. STEINDEL: I will go into that, Jeff, at the end. Yes, and it was something that did prove to be interesting.

The questionnaire asked the month and the year that you started and completed a phase. What was interesting was is that it didn’t ask the date, that would be an interesting detail to have based on that the transaction rule goes into effect in the middle of the month, so it’s difficult to project, but I just estimated for the sake of producing some information that a phase started and ended on the first of the month so I could calculate the number of days people were estimating it took that process. And I thought this would be useful information to the group to see how long it might take for the people to put the transaction process in place, and I won’t go through this beyond just very, very quickly. The awareness phase, the maximum number of days people indicated was 335, and the median number of days was 61. For the operational phase, the maximum number of days someone indicated was just over 3200, and the median number of days was 184, which is still a fairly substantial number. The testing phase, again, the maximum number of days was just over 3100, and the median number of days was 153.

What I usually find when we’re asking a large survey like this is while its interesting to look at the max and the min, these can tend to be outliers for various reasons, and the numbers to focus on is more the five to 95 percent range. And correspondingly, the 95 percent number for awareness was 273 days. For the operational phase it was 550, and for the testing phase was 489, which is a little bit more reasonable than over 3,000 days.

I did also calculate a number for the total process, the number of days that they had indicated from the start of the awareness process to the end of the testing process. Now you need to realize that not all of the people who responded, responded and gave numbers for each one of these phases. When you think about it, half the population said they hadn’t even started, so these do not represent the full population, and the numbers are given.

For the total process, the median number of days was 304, which is just less than a year, and when we consider that none of the people had indicated they started I think that’s something to consider. The 95 percent number was 669 days, and the maximum number of days was just under 3,000 days for the whole process. Now I took these from the first day to the last day, so you notice there’s a little disconnect on the actual dates people were reporting for each one of the individual phases, and did not analyze that.

They also ask where you are in the process, have you started or completed certain key steps. Have you reviewed the current process? 42 percent said they have not reviewed the current process, 50 percent said they had just started the review of the current process, and seven and a half percent indicated they had completed the review.

For computer software development, 54 percent had not started any, 43 percent had completed it, and three and a half percent indicate had started it but not completed it, and three and a half percent had said they completed it.

Computer staff training, 55 percent had not started the process, 43 percent had started the process but not completed it, and two and a half percent had said they completed it.

That completes my presentation of it from a numbers point of view of what we saw in the databases. Getting to Jeff’s question that he asked earlier, one of the things that we were asked to do under ASCA was to see if we could give some examples of best practices. In looking at the database, one of the problems we had was that there was really no practice associated questions asked, so it was very difficult to say what a best practice could be if there were no practice questions.

The approach that we did take was looking at everything that was asked, is that there may be certain attributes that existed in the group that had completed all the phases, and we can’t necessarily say that completing all the phases, the people who did that, exhibit best practices. I mean we can say one thing, they may not have exhibited any best practices because they may have completed all the phases against a standard that is not appropriate, or they may have completed them in a way that foresaw the future standards since it was out there, or they may have completed it in such a way that they could change over to the standard if and when it was adopted, and these would really be best practices. But we had no way of knowing that. But we saw that that was the only group that we might be able to make some type of meaningful statement about.

So we did logistic regression analysis against what we looked at as certain key factors that might contribute to completing testing. And these factors were entity type, the estimated cost, the number of delay reasons, the provider type, the use of a contractor, and the geographic location. For geographic location, and you’ll find breakdown table by geographic location, we chose to use the CMS regions that the entity was located in. There was two reasons for this, one it provides a convenient geographic breakdown of the country, and the other is this happens to be a CMS activity, so we thought that might provide some useful information to them, what they can gleam from it we’re not sure, but why not, if we had to do a geographic breakdown we could choose one.

We chose to talk about only those significant factors that showed an odds ratio better than one, through the 95 percent confidence limits, not that calculated an odds ratio but had the lower 95 percent odds ratio above one. So these are factors that we think are really significant with respect to those that have completed the phase three of testing. We did find that those that were clearinghouses when compared to providers had a better chance, and those that fell in the group of clearinghouse, health plan, and provider versus provider had a better chance of completing phase three. So I think in answer to Jeff’s question, before did we find any breakdown by entity type, I think we can say that clearinghouses had a tendency to complete phase three more than the other groups.

From a cost point of view, those that were doing this at less than $10,000 dollars and those between the range of $10,000 and $100,000 dollars, the lower ranges of the cost estimates had a better chance of completing phase three than those who responded that they didn’t know.

From a provider point of view, dentists versus other had a better chance of completing phase three. I see Kepa grabbing the phone.

DR. ZUBELDIA: Can I make a comment about that? Because in your provider type table, it shows that dentists represent 8.5 percent of the providers, and you’ve got a total of 35,000 responses from dentists. I understand there is more like half a million dentists. So you got about ten percent of the dentists to respond.

DR. STEINDEL: I think Mike, and we made the comment in the introduction, that what we are specifically talking about with respect to this population is those people that responded and asked for an ASCA extension.

DR. FITZMAURICE: It is also possible, but not likely that many of those dentists are in groups and one dentist reported for many of them, I think that’s the answer.

DR. COHN: What I was actually going to comment, and this is for physicians also, is that the standard is generally small to medium size practices for many of these, now I can’t speak for dentists, but certainly for physicians and so knowing that there was just one submission per group, so --

DR. ZUBELDIA: Most dentists don’t work in large practices.

DR. COHN: Well, that’s what I said, small to medium size practices.

DR. STEINDEL: I think that there’s a lot of discussion that could be made in, as we go down the list I think we can discuss all of them from the same point of view because durable medical equipment suppliers versus other showed a very high odds ratio for completing phase three versus other. Hospitals showed a goods odds ratio for completing it as did pharmacies. I’m not sure, I’m sitting in the position of I’m reporting the data and I think there’s a lot of, if I move back to my other seat and got into the discussion mode I think I would join in on a lot of discussion on what this means.

DR. FITZMAURICE: I think too that those groups that Steve just mentioned have people whose job it is to focus on the business practices whereas many smaller providers are focused more on the patient activity and trust somebody else to take care of their billing, a clerk and then a billing service.

DR. ZUBELDIA: Can I give you my interpretation on the dentists? About 17 percent of the dentists file their claims electronically, you got those dentists to file for the extension and they’re saying they’ll be ready because they’re going to file electronically, the majority of the dentists, many are filing electronically, they didn’t file for the ASCA extension and that’s why you’re getting those numbers so skewed.

DR. STEINDEL: I think if we take off my data reporting hat I would somewhat agree with the observation that Kepa is making. One interesting thing that we did notice was those that used a contractor versus those that were undecided about contractor use had a greater odds ratio of doing provider three, completing phase three. There was a couple of regions that showed a significant odds ratio of completing phase three versus region ten, which was our standard region for comparison. I don’t know what to make of that, because we haven’t analyzed what’s in those regions, but I think some of this may be due to locations of education programs or locations of significant groups of entities that may have completed phase three. I don’t think it has to do with CMS region, I just think it has to do with just where in the country they were.

But that is our report on what we found from the ASCA database, I’m open to Committee comment if they would like us to look at other areas when they have a chance to more completely look at the report and the breakdowns.

DR. FITZMAURICE: I think what we’re looking for is first of all satisfying the Congressional requirement and looking for guidance from NCVHS as to what additional might be required to complete the Congressional requirements. Then secondly, what other analyses might you find interesting that we could accomplish.

DR. COHN: First of all I want to thank you both, I mean I think this is very good work, let me start there. Jeff do you have a comment?

MR. BLAIR: Yes. I like that your report we decide type of attitude --

DR. FITZMAURICE: I’m married, I’m used to that.

MR. BLAIR: Were you able, or is it possible, to look at a provider sector like, for example hospitals, where there seem to be a fairly good number of that sector that got through phase three and take a look, and for those that did go through the process, that say that they’re ready, to take a look at the timeframes they said that it took them for testing and for training, and that that might be instructive to us for those that still have to go through the process.

DR. STEINDEL: We could do the analysis of days it took by entity type for each phase of the process.

MR. BLAIR: I don’t think of an exhaustive study, I just wanted to see if it fell within the boundaries that we’ve said, we’ve wound up saying allow six months for testing, did it pretty much take that long for most of those entities?

DR. FITZMAURICE: For those who were completed, Jeff, like the 3.7, how long did it take them to do each phase.

DR. ZUBELDIA: I’m trying to see if I can resolve in my mind this, somewhat of a paradox here, because you’re reporting that in the odds ratio of a clearinghouse or a clearinghouse/health plan/provider being done with phase three, it’s 3.5 or three times higher than for a provider being done. But on the other hand, if you look at the reasons for delay, 33 percent of providers are waiting for their clearinghouse. So there must be a miscommunication somewhere if the clearinghouses are three times more likely than the providers to get done, and the providers are saying we’re waiting for the clearinghouse, they’re probably not talking to each other or something.

DR. STEINDEL: It may be that, and it may also be that even if the odds ratios are very significant, the number of clearinghouses is not that large.

MR. SCANLON: I guess the more basic issue is that we probably don’t have any good control numbers, we have some estimates of what the total number of covered entities is and we published those in the rules, the impact analysis, but again, we were using the best information available. But I don’t think anyone really knows the total number of covered entities, so you almost have to start there to see how many in each of those categories of covered entities actually applied for an extension and does that mean the others are ready or that the others are not even aware. So there are a lot of causal inferences here that you simply can’t make.

We may want to look sort of how the number of folks requesting an extension in each of the major categories of covered entities comports with the total numbers that we published in our reg, not that they’re necessarily correct but just to see what percentage of each of those segments even filed an extension. With hospitals it looked like we had more than 8,000 filing, which is probably more than, serving more than 75 percent of hospitals, it may be virtually all of them. With providers we had very few, even physician practices and individuals, I think there are what, 700,000 practicing physicians in the U.S., we don’t know how many practices there are but we didn’t get anywhere near half of those. You’d almost need to know what the total covered entity would be.

DR. STEINDEL: Kepa, the other thing is we have no information like on clearinghouses what their volume is, so it may be that it’s a low hanging fruit from clearinghouses, ones that handle low volumes of transactions. And the providers are waiting on people who are handling higher volumes of transactions, we have no way of knowing that.

DR. COHN: Other comments? I think we can probably try to massage this data to death which I’m certainly not supportive of given that we’re supposed to get into testing in less than a month. So I would certainly encourage if there are Subcommittee members who have specific issues that they want Michael or Steve to explore further, send them an email, I think we’re getting, this looks to me like almost the final report, so if anybody has, Steve, comment?

DR. STEINDEL: There was one number, since I was working from the slides and not from the report, there was one number that I felt I should mention, was I did do a calculation of those, the percent of people who indicated the day that they would finish testing, and I tested it against October 31st because we didn’t ask for the day you actually would complete testing so I gave them the benefit of the doubt and I gave them the whole month, and still 3.9 percent of the people indicated a day beyond that date.

DR. ZUBELDIA: And some people indicated ten years beyond this date.

I want to go to what NCVHS can do, it’s nice to look at the numbers but our role here is to provide some assistance to the industry to help them comply with the rules without spending ten years in testing. And in looking at the reasons for the delay, there are some things that I don’t think we can do, buy them hardware or give them staff, I think that’s kind of out of the scope. But there are some things that perhaps we can influence or help or assist or cajole, 46 percent are waiting for some sort of clarification on the standards or standards information.

DR. COHN: This was before, this was done last year.

DR. ZUBELDIA: Before the addenda were published, I understand that. 34 percent were working on clarification of some sort. Again, before the addenda, but those are very substantial numbers and other than that, give them time or waiting for vendor or clearinghouse, I’m not sure that there’s much we can do about that. So I think that the types of interventions that NCVHS can recommend based on these data is rather limited.

DR. COHN: I sort of agree with you looking at this, once again I do think we need to get a final report and get it up onto our website, so that’s number one. And number two, Karen and I were talking about this, looking at this data I think one would be hard pressed not to say that increased education would be a valuable item here. And indeed, I think one of the things that we were proposing doing with CMS has been developing these short informational and educational, I won’t say pamphlets, but documents, this is that we might want to have the NCVHS website actually have them available or create a link to the CMS website so that they can get access to all of that. Because I think education sort of goes through this as, the question is first of all, did everyone who was supposed to file the extension, of course we have no way of knowing based on the data, but one would assume that probably there were some groups and some individuals who did not file, so education would be helpful, this is one way to do it. The question is is are there other education tools we should be recommending in terms of all of this.

The other piece is, and we really didn’t talk to WEDI about it during their session this morning, recognize that they have a number of white papers we might either want to recommend that people who are having issues review the white papers and we’ll give them a link to the website or at least say you might want to consider looking at the WEDI or WEDI SNIP website for the white papers. Those are two things that I would think that we can do that might meet the requirement in that legislation.

I’m obviously open for other ideas or if anyone here thinks that these are bad ideas we can sort of consider other options. Does anybody have? I do think that time is sort of getting to be of the essence to get this as a finished, published, and I guess I would say for the Subcommittee recognizing that we just received this a couple of hours ago, I think I would like everybody to review this over the next week or ten days and then if there’s changes to the draft document or other things that need to be explored, let’s send those to Mike and Steve, let them finish it up and then we can get it up on the website. Is that a --

DR. FITZMAURICE: Simon, should this go through the full Committee first?

DR. COHN: Well, that’s September, I don’t think this is --

DR. FITZMAURICE: No, it’s June.

DR. COHN: I apologize, yes it’s --

DR. FITZMAURICE: It could also be done through email, through executive committee.

DR. COHN: Maybe executive subcommittee.

DR. FITZMAURICE: I’m just asking procedure, I’m not advocating one or the other. Peer review is always good.

DR. COHN: Marjorie, thoughts?

MS. GREENBERG: Would this particular document --

DR. COHN: What sort of approval process should this go through?

MS. GREENBERG: Well, I think first the Subcommittee who understands this the best, presumably, needs to look at it, I think first we need a review by the Subcommittee which we’ve started, and how much time did you want to give people?

DR. COHN: I was going to give them a week.

MS. GREENBERG: And then I don’t know if there’s any additions or changes that are made to it, then I think we could circulate it to the full Committee and give them a short period of time also.

DR. FITZMAURICE: Maybe handle all this by email.

MS. GREENBERG: By email, yes, I don’t think it needs like a formal approval process, I think this was an effort to analyze this, but then we were going to put it up on the NCVHS website, also with suggestions of other links as you said, and so at that point we send it out the full Committee, tell them that’s what we’re doing and then if they have any other suggestions of links or useful materials they should let us know.

DR. STEINDEL: Simon, I’d just like to be clear about what we’re talking about the document, and if we’re talking about a document with recommendations from the Subcommittee and comments from the Subcommittee, I think that’s an extension to this document. If we’re just talking about the data that was observed than this document is fine.

DR. COHN: This document does not have recommendations and I wasn’t suggesting that we quickly develop some recommendations. But on the other hand, if there are things that need to be further analyzed or errors in the report, then we need to have that.

DR. STEINDEL: Extending the facts to other areas and correcting, I tell everybody who I hand documents to I am the world’s worst proofreader, so I’m sure there are numerous areas that need correction in this first draft.

DR. COHN: But as I say that, I mean look at the Subcommittee, are you all comfortable with this sort of a document? I think it makes sense, otherwise if we start making major recommendations I think that really will be something that would have to be handled at the June full Committee meeting, likely as a discussion item and all of that.

MS. GREENBERG: My sense is that there isn’t time but it probably wouldn’t be fruitful for the Committee itself to be developing materials when solid materials are being developed by CMS and WEDI in particular. But I think it would be a good idea for the Subcommittee members, if they haven’t already done so, to review these other documents. I mean I think, there’s reason to have confidence in CMS and in WEDI but on the other hand I think maybe if you could kind of spread it around or something, but just to see whether you see there are any gaps in documents that are available, just as we did, as the Committee did with the privacy, are there audiences that aren’t being addressed, are there topics that maybe haven’t been addressed, just so that, not to lead towards the Committee developing additional documentation but maybe as suggestions to CMS or WEDI. So I would suggest that.

DR. COHN: Karen, did you have a comment, suggestion?

MS. TRUDEL: A possible suggestion would be to add just one paragraph at the end of the first page where it talks about analysis, and make several of the points that Kepa did, which is some of these reasons are not amenable to NCVHS solutions, and boil down the several that we think we can address and say they primarily speak to outreach and to a need for materials, and that therefore the Committee feels that they’re best, the best way that they can meet the intent of the law is to highlight or put a spotlight on several resources that speak to these shortcomings, and therefore we are providing the following links to the following websites. That would just sort of tie it all up.

DR. COHN: Are we in agreement about that? Comments?

DR. FITZMAURICE: Who will supply the websites?

MS. TRUDEL: I can do that.

DR. STEINDEL: Can you supply some draft language for that paragraph?

MS. TRUDEL: Sure.

DR. COHN: If it’s ok, let’s move on to our other items. Now we have a couple things to go through, one was we wanted to talk about the ICD-10 cost/impact, I think a brief update on that, and I want to talk briefly about upcoming meetings, and I believe there was a request for public testimony I believe, we’ll do that after our ICD-10, and ask you, a total of three minutes if you could? Ok, great, ok, thank you. And then we will adjourn. Donna, would you like to talk about the ICD-10?

Agenda Item: Status of ICD-10 Cost/Impact Study - Ms. Pickett

MS. PICKETT: Dr. Cohn and Committee members, we finally have a signed contract, the ink is dry, and to that end we have also forwarded to RAND background information primarily consisting of testimonies that have been provided to the Subcommittee on ICD-10-CM and ICD-10-PCS. We’ve also provided them other materials that have come into the Committee, including letters and such. We’ve also provided them with the actual transcripts from the websites so that they have a fuller understanding of all the information, trying to help fill in the gaps, particularly since we’ve lost time we wanted to make sure we could sort of put this back on track and expedite the process.

Also, as of yesterday, I have spoken to the principal investigator and others at RAND to obtain their calendars for conducting the kick-off meeting, so that information should be available to me when I’m back in the office tomorrow. Once I have that information I will then forward the information out to Dr. Cohn for availability for our conference call.

DR. COHN: We I think had been, in terms of the timeframe assuming that we would be able to review results in the May Subcommittee meeting and bring it back to the full Committee in June. My presumption is based on what we’re seeing is that maybe it will be reviewed by the Subcommittee in August, going to a September full Committee meeting, is that a --

MS. PICKETT: I think that’s a fair assessment. The other reason we wanted to expedite getting documentation to them was to assist them in identifying how the timeframe should be amended, since obviously it is now a lot different than what was originally proposed.

DR. COHN: Ok, great. Questions about that? This will be an ongoing item for the next several months. Before we go into planning, did you want to make that public, Michael did you want to make a comment?

DR. FITZMAURICE: I had a question, specifically they’re doing a cost/benefit analysis of moving from ICD-9 to ICD-10 for diagnosis or for procedures or both?

MS. PICKETT: It’s for both, it’s for ICD-9-CM to ICD-10-CM and ICD-10-PCS.

DR. FITZMAURICE: For procedures or for diagnosis and procedures.

MS. PICKETT: Diagnosis and procedures, 10-CM for diagnosis, ICD-10-PCS for procedures.

DR. FITZMAURICE: Thank you, Donna.

MS. BEBEE: Are there dates, Donna, in the contract?

MS. PICKETT: The original statement of work was January to May.

MS. BEBEE: Well, I mean I know it has to be modified, is that what you’re going to talk to them about?

MS. PICKETT: Right, that will be part of the agenda for the kick-off meeting. And again, that was one of the reasons we wanted to get material to them sooner so that they could assess that.

DR. COHN: Would you please introduce yourself?

Agenda Item: Public Testimony - Mr. Martinez

MR. MARTINEZ: Yes, for the record my name is Tony Martinez, I’m with the firm of Martinez, Bass and Associates, here on behalf of Alternative Link and the Foundation for Integrative Health Care. Just simply briefly would like to inform the Committee on the preliminary registration data for the demonstration project that has been authorized by the Secretary of the Department of Health and Human Services, and actually its quite compelling. Basically the Foundation and Alternative Link has received over 8,223 raw registrations, not including all the faxes and hard copy registrations that have entered.

Among the entities that have registered include over 146 insurance corporations and conventional health plans, 43 HMO’s, 12 state Medicaid programs, 129 different governmental agencies, 35 different integrative delivery networks, 131 hospital systems, PPO’s and specialty PPO’s 48, IPA’s over 58, leading medical schools we have 16, academics 961, third party administrators 24, application developers and service providers 111. In fact we were really surprised and pleased that there is such great interest in the ABC codes and the fact that you have such a wide breadth of interest in the codes I think should be actually good news for the health care system because it sends a message of the need to look at developing, how we’re developing the HIPAA process and coding and all the different types of health care transactions that are out there. So we look forward to keeping the Committee informed.

And one other interesting thing, just as we were listening to the testimony today, it is interesting that the same challenges that the Committee is reporting regarding compliance with HIPAA, regarding the entities in terms of compliance, similarly Alternative Link and the Foundation has encountered the same types of challenge, we’re trying to get everybody who should be involved with the project, get them on board, get them registered, get them involved with the process. And the same kinds of difficulties are there, so we look forward to sharing with the Committee our findings of the process and assist the process overall. So thank you very much for this opportunity to inform the Committee.

MS. BEBEE: I didn’t hear you right from the start so you might have said this but I apologize. You said around 8,300 have applied?

MR. MARTINEZ: Just on-line, that’s not including, we’re still tabulating our fax registrations and people that have sent in registrations by mail.

MS. BEBEE: So is this for the waiver, is this for the demo, is this for both?

MR. MARTINEZ: This is for the demonstration project.

MS. BEBEE: So you’re going to have all those people and all that data over the course of the two years or whatever?

MR. MARTINEZ: Yes. Thank you very much.

DR. COHN: Thank you very much for your testimony.

Agenda Item: Planning for Future Meetings - Dr. Cohn

DR. COHN: Ok, let me just sort of quickly remind everybody about upcoming meetings and all this. Our next scheduled hearing is May 21st and May 22nd, May 21st will be devoted to issues related to PMRI terminologies, May 22nd at this point is sort of to be determined. We had reserved it for ICD-10, it still may be appropriate but certainly the final report will not be in at that point in time.

I think as you heard we are likely to do something to be determined in April, whether face to face, conference call or otherwise. Also I believe Marietta will be sending out later this week querying the Subcommittee on hearing dates for the last half of the year, dates in August, October, and December. Just watch your email for those.

Are there any other issues coming before the Subcommittee today? Ok, thank you all for your participation, and thank you very much. The meeting is adjourned.

[Whereupon, a 12:32 p.m., the meeting was adjourned.]