[This Transcript is Unedited]
Crowne Plaza Hotel
1489 Jefferson Davis Highway
Arlington, VA 22202
Agenda Item: Call to Order, Introductions, Review Agenda - Dr. Cohn
DR. COHN: Good morning, I want to call this meeting to order. This is the first day of three days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. Those of you have been members for a while or been observers of both Subcommittee and full Committee know that normally our hearings are only two days. I think this three day session sort of reflects the extraordinary amount of work that’s coming before the Subcommittee and the full Committee at this point.
I think as you know the Committee is the main public advisory committee to HHS on national health information policy. I am Simon Cohn, I am chairman of the Subcommittee, and the national director for health information policy for Kaiser Permanente. I want to welcome fellow Subcommittee members, others here in person, and I will apologize since I’m the, you’re all looking at my back, but obviously if there are issues that you want to comment on just come to the microphone and we’ll insinuate you into the discussion. I also want to welcome those who are listening in on the internet. I want to remind everyone to speak clearly and into the microphone.
This morning we are focusing on the implementation of the HIPAA administrative and financial transactions final rule. Karen Trudel will lead with the HIPAA update, thank you Karen for being here. Then we will hear from testifiers on the status of HIPAA implementation. I think as you all know we’ve had a number of conversations with WEDI on the issue of transition and contingency planning for this final rule. On April 15th they sent a letter to Secretary Thompson on the transition, we’ve asked them to brief us on the issues and possible recommendations. Then we have asked others from the health care industry to share with us their thoughts on the transition and whether recommendations from the NCVHS to the Secretary are appropriate or necessary on this issue.
This afternoon we will be focusing on the combined health care informatics initiative. Now that the initiative and first set of recommendations have been publicly announced by the Secretary we want to spend some time discussing and getting public input on their outreach plans and planned portfolio. And that’s of course just today. Tomorrow and Thursday morning we will continue our work on health care terminologies, Jeff Blair our co-lead and co-chair for clinical issues will lead those sessions.
Finally Thursday afternoon we will talk about the federally funded ICD cost impact study being undertaken by RAND. And hopefully somewhere in all of this we will find some time to discuss the interim enforcement rule and whether or not it is appropriate and timely for us to develop a letter for the full Committee on that issue.
With that short agenda we will 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. With that, Jeff would you like to introduce yourself?
MR. BLAIR: Jeff Blair with the Medical Records Institute, vice chair of the Subcommittee, member of the full Committee, and there’s nothing that I can think of to recuse myself of. I do want to indicate that I’m a member of HIMSIS, HL7, ASTM, and I think that that’s all I can think of that might be pertinent.
MR. HOUSTON: I’m John Houston with the University of Pittsburgh Medical Center. I have nothing to recuse myself of.
MS. PICKETT: Donna Pickett, National Center for Health Statistics, CDC, staff to the Subcommittee.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the Subcommittee and liaison to the full Committee.
DR. FERRER: I’m Jorge Ferrer from the Centers for Medicare and Medicaid Services, staff to the Subcommittee.
MS. GRAHAM: Gail Graham, Department of Veterans Affairs, staff to the Committee.
MR. SCANLON: I’m Jim Scanlon, I’m with HHS, I’m the executive staff director for the Committee.
MR. CUNNINGHAM: I’m Carl Cunningham, I’m director of the Practice Management Center of the American College of Physicians.
MR. RISHEL: I’m Wes Rishel, I’m the chair of HL7, but this morning I’m speaking on behalf of Gartner.
MS. BEBEE: Suzie Bebee, NCHS, staff to the Subcommittee.
DR. HUFF: Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City. I have potential conflict of interest in discussions of both HL7 and LOINC, and potentially if there are any issues that come forward about CPT codes.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation. I’m a member of WEDI and AFEHCT that will be testifying today. Claredi has a contract with the American Hospital Association and we have business relationships with probably everybody that is going to testify today concerning the transactions.
MS. FRIEDMAN: Maria Freidman, CMS, staff to the Subcommittee.
MS. TRUDEL: Karen Trudel, CMS, staff to the Subcommittee.
DR. COHN: Kepa, I guess I should ask before we do further introductions, does that mean you need to publicly recuse yourself from any of the discussions or is it just a point of information?
DR. ZUBELDIA: Can I go home?
DR. COHN: No, but thank you for sharing.
DR. ZUBELDIA: Just a point of information.
DR. FRANCHEE(?): Beth Franchee, Department of Veterans Affairs, I am on the demographics workgroup for CHI.
MS. LUTKE(?): I’m Jennifer Lutke with MISIS(?) Health Care Systems.
MR. CUTRELL(?): I’m Rusty Cutrell with MISIS Health Care Systems.
MS. WILLIAMS: Margo Williams from the American College of Physicians.
MR. MCGLAUGHLIN(?): I’m Mark McGlaughlin with McKesson.
MR. ARGES: George Arges with the American Hospital Association.
MR. VERRY(?): Peter Verry, the Peter Verry Company.
MS. LESCH(?): Kathy Lesch with the Kever(?) Company.
MR. JAMES: Linnel(?) James, Blue Cross/Blue Shield Association.
MR. BECHTEL(?): Don Bechtel with Siemans Health Care Data Exchange.
MS. BITTNER(?): Debbie Bittner, Westat Research.
MS. DENBO(?): Anne Denbo, Westat Research.
DR. CHUANG: Ian Chuang with Cerner Corporation.
MS. SHOVE-BROWN: Maureen Shove-Brown with Zero One Concept, I’m project managing for Care First, Blue Cross/Blue Shield.
MR. RIDGE: John Ridge with the American Neurological Association.
MR. MILLER: David Miller with United Health Care.
MR. JONES: Ed Jones, health care consultant and chair, Workgroup for Electronic Data Interchange.
MR. LAZARUS: Steve Lazarus, president, Boundary Information Group, immediate past chair WEDI.
MR. TENNANT: Robert Tennant, Medical Group Management Association.
DR. FAUGHNAN: John Faughnan, McKesson.
DR. LEVY: Brian Levy with Health Language.
MR. CHARLES: Mark Charles, Altarum(?) Institute.
MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.
MS. GILBERTSON: Lynn Gilbertson, National Council for Prescription Drug Programs.
MS. ECKERT(?): Karen Eckert with Medispin(?).
MS. WATERS: Cindy Waters with Perse(?) Technologies.
MR. DECARLO(?): Michael Decarlo with the Health Insurance Association of American.
MS. CONNOR: Kathleen Connor, Fox Systems.
MS. GRECCO(?): Kim Grecco with Hogan and Hartson.
MR. RODY(?): Dan Rody with the American Health Information Management Association.
MS. BRAGE(?): Kathy Brage with the American Health Information Management Association.
MR. MOORE: Bob Moore with Computer Sciences Corporation.
MR. EMERY: Jack Emery with the American Medical Association.
MS. BARTLETT: Melissa Bartlett, American Association of Health Plans.
MR. WILDER: Tom Wilder, American Association of Health Plans.
DR. COHN: Well thank you for all joining us today. Before we start our first session which I think we’ll be leading off with Carl Cunningham, I do want to of course disclose, even though I don’t think there’s anything like Stan that relates to CPT coming before us certainly this morning and probably this afternoon, obviously if there are issues I will be recusing myself. With that, Carl I think you’re going to be leading off the first session as I understand, oh I’m sorry, I will apologize to everybody, the three hour time change is beginning to impact me as you can tell. Karen would you like to lead off?
Agenda Item: HIPAA Update - Ms. Trudel
MS. TRUDEL: Why thank you since you asked me. No, I do just have a very short update on regulations as each time goes by when I report happily there are fewer and fewer regulations to report on which is a good thing. We are still working through the process of clearing the national provider identifier final rule and the health plan identifier proposed rule. The claims attachment proposed rule is in a slight holding pattern right now because both Health Level Seven and X-12 have asked for a little bit of additional time to perfect and ballot and put out a newer version of the standard using a different architecture. So we will be allowing them some time to do that.
The only other regulation that’s really in process right now is the enforcement, what we’re calling the substantive rule, the procedural rule which essentially sets out all of the legal processes was already published and to kind of counter two of them, the substantive rule will define things like what is a violation and how you count a violation, is it one disclosure or is it one claim or is it one error on a claim, some of those issues are very thorny and I can imagine that the regulation will be fairly extensive and I’m assuming that we’ll probably receive a lot of comments on it. That one is still in process and I don’t believe it will be published until into next fiscal year as a proposed rule, and that’s really all I have to report on right now.
DR. COHN: Any questions for Karen?
MR. RISHEL: I have a question. Will the substantive enforcement rule go through an NPRM and then a final rule or will it just be published?
MS. TRUDEL: No it will definitely be a proposed rule first.
MR. RISHEL: Thank you.
DR. COHN: With that my apologies, Carl I think it is your turn at this point, if you’d like to lead off this discussion of compliance readiness.
Agenda Item: Compliance Readiness Update: What We Know So Far - Mr. Cunningham
MR. CUNNINGHAM: I would be delighted, I don’t think this mic’s going to do anything for us though. If you can all hear me I’ll be glad to begin then.
MR. BLAIR: I hear you but I don’t think the people on the internet can hear you, maybe there’s another mic that you can use.
MR. CUNNINGHAM: Well, first of all I want to thank you all for inviting us to come and speak today. The American College of Physicians is the parent association for almost all internists in this country, there are 115,000 members of that association. I’m responsible for a center for practice management which advises them on the management of their business affairs and the operations of their practice.
I’ve been asked to talk to you a little bit about the status of implementation in these medical practices around the country because I know there’s been a lot of concern about what has been going on. And I think first of all it’s important to paint for you the setting in which this takes place because our membership is, 70 percent of our practicing physicians are in small practices, 20 or less physicians, half of them in practices of one to five, and a third of them approximately in one and two doctor practices. These small practices, the smaller that you get, the more it is that these practices resemble a mom and pop business, not unlike the family owned dry cleaners, convenience store or restaurant that’s somewhere in your neighborhood. And in that setting you do not find that the business retains financial reserves or retained earnings, you will not find if you look inside of it any lawyers, MBA’s, accountants, systems managers who are organizing and planning the administrative functions of these little businesses.
What you will find is that all those functions are handled by a single office manager, this officer manager probably came up through the ranks, she, and I use that term advisedly since almost all of them are she’s, probably or may at least not have a complete college education. She goes in each day and struggles mightily trying desperately to keep the patient flow going, put out the fires that are going on, and taking care of the basic business essentials that that practice needs to have taken care of to keep functioning. The environment is such that she is constantly pressured, and the declines or the limitations in Medicare reimbursement and the increases in malpractice or the dramatic increases in malpractice insurance have put additional financial pressure on these practices.
And so they are struggling with this kind of a setting and into drops HIPAA. First the rather intrusive and complex privacy rule, and they struggle mightily. The first reaction on the part of the physicians I can only describe as sputtering rage, because everything they try to do is to minimize the distractions in their business operations and now comes this monster that they have to implement. That reaction was followed by one of denial. But eventually they kind of recognized that patient confidentiality has been with them for a long time, it’s something they know something about, the rule was modified to make it easier to implement, and they finally said ok, we’ll get on with it and do it. And they did it.
Now interestingly enough, the reaction to the transactions rule was almost totally the opposite, sort of an eerie calm. And the reason for that is very simple. They don’t know very much about computer systems, so they naturally have relied upon their practice management system vendor to handle these functions for them. And they expect, fully expect right now that that will be taken care of or that the transactions rule updates will be taken care of for them by that vendor and they don’t need to really worry about it too much. That is a dangerous assumption as we all know because among other things they aren’t probably asking the questions, if they ask at all of their vendor what is my status, they’re very likely to get a local salesperson who will say don’t worry about it, you’ll be taken care of, everything is ok. And they’re not sophisticated enough to ask the follow-up questions, the detailed questions they need to know the answers to, and they probably are not sophisticated enough to know that they, too, have a role that they’re going to have to do some things internally particularly with regard to the content. And meanwhile they’re relying on a vendor who is in fact not a covered entity and not compelled by the law to meet the October 16th deadline.
So, knowing about these vulnerabilities, knowing about their preoccupation with the privacy rule up until this time, we’ve done a lot of work trying to get their attention about transactions. And then along about February or so we began hearing these really scary reports that maybe the physician practices in the country are doing nothing about transactions. And we therefore, but there was no information, I mean there was no data, it’s just people are saying looks like medical practices aren’t doing anything, they’re all asleep. So we have an annual meeting that takes place in April, early April, and I decided that we would try to get some sampling of some physicians, we would try to get a little bit of a pulse taking if you wish. And so we tried a rather informal and I assure you it is not a scientific survey, it is not reliable data, it was conducted at our annual session, or our annual meeting.
The main distribution was at two workshops that we conducted. They were all physicians, and I’ll come back to that a little bit later. At one of these courses it was a course on HIPAA, what’s it all about, what do you got to do and that sort of thing, so they had some instruction there. The other course was a finance course that we conducted, we didn’t mention HIPAA at all except ask them to fill out the survey form. And there was a few samples that were collected at our booth in the exhibit hall as well, where of course there was no instructive given either.
Now this rather unscientific cut at the thing was something which gives you not very good data. The sample size, only 92 respondents, way too small particularly given the size of our association and even the 6500 attendees at the annual meeting. There’s a possibility of bias creeping into it, both by the people that we selected and by the fact that even going to an annual meeting is sort of a form of selection indicating you may be a bit more into this stuff and sophisticated than the run of the mill member. And finally there is a potential bias in that less than half of the people attending these courses responded. Nevertheless, this turns out to be the kind of information that isn’t being collected anywhere else.
There is in the handout attachment B to the appendix where my slide presentation is contained you’ll find the actual questions we asked. There were sort of six, they’re progressive and an indication of the degree to which the practice is involved in HIPAA implementation, starting with a simple question about are you required to comply, in other words are you a covered entity. Have you discussed with your vendor the question of TCS? Have you verified with the vendor that you’re going to be able to submit 837’s come October 16th? Have you already updated the practice’s software, have you begun testing, have you identified the new required elements that, the content elements that you’re going to have to come up with?
Now this is the results of that survey. At the beginning you see a very close correlation between the different venues in which we conducted this thing, the results sort of more or less fall in the same category. It seems pretty clear that most of them have figured out whether they’re CE’s or not, covered entities. A high percentage is saying they’ve discussed with their vendor already this question of implementing the transactions rule. A pretty good percentage have indicated, more than a majority, that they’ve verified to be able to send an 837 when the time comes. And a pretty high percentage indicates that they have updated their software.
Now up to this point I’m kind of with them, I think this probably does reflect what’s going on and that they have started, they are not totally asleep, they’re not doing nothing as I had begun to hear. I have some doubts about this data right here because my sense is that it’s unlikely that the vendors have actually been able to get to well over half of our practices and get their software updated, could be. Where I begin to have real doubts is over in here, because as you look at this data here, not only is it a little bit counterintuitive, it’s a little bit inconsistent. I’ll give you an example. I find it kind of interesting that in this case more people are actually testing than have already updated their software to make it possible to test. I also find it a little peculiar that the percentages here for the HIPAA course where they were given instruction and knew a bit about what we were talking about are much lower, not hugely lower but they are lower, than for the finance course and particularly the booth. It would almost suggest an inverse relationship between knowledge and implementation, that strikes me as a little counterintuitive and a little bit suspicious.
Now there are some conclusions that you can draw and I’ve drawn part of them already, and that is that yes, they are aware of what’s going on and they’re trying to do something about it. And they probably have contacted folks. And they maybe have installed the updated software already. Whether they’ve gone beyond that or not I think is what is in question, and there is a theory as to why we might have gotten such a high indication of practices having already investigated the content elements and have started testing. And that is that physicians were our respondents and physicians don’t know very much about the implementation aspects of running a medical practice, they leave that to staff. And this is particularly reinforced by some results of a show of hands at a seminar on HIPAA conducted in upstate New York recently, where most of the people in the room were staff rather than physicians. And when they were asked all these similar questions, not exactly the same questions but similar questions, they’re answers were very consistent for the first few questions, yes indeed, they’ve contacted the vendor, they know what’s going on and they’re ready to go, and no indeed they haven’t done hardly anything, very few of them had done anything towards investigating the content that’s going to be required that’s new, educating their staff, or conducting any testing. And we think that that tends to support the theory that I gave earlier that maybe the physicians simply didn’t know very much about what was going on in their practices once you get beyond the point of saying yes, we as the board or I as the managing physician have decided we will do this, now Mary go ahead and do it. Well Mary is trying to now have to deal with the implementation details that may not have been happening.
I’d like to add one other piece that we just recently came across which helps fill out this picture I think. PAHCOM is the Professional Association of Health Care Office Management, it was office managers, this is the professional association of office managers in the country, and they have about 3200 members, they conducted a survey in March, covering a bunch of things including one question about HIPAA, particularly are you testing. And these were the results they got. The surest one is this one here, 18 percent said they’d already started testing. 43 percent said they had scheduled the testing.
MR. BLAIR: What was the date of that particular survey?
MR. CUNNINGHAM: The results, the deadline for turning in the survey was sometime in like about the 20th of March, somewhere in that range, and I don’t actually know when it started. If you’re interested in it it’s all posted up here, it’s in their May/June Medical Office Management Newsletter, so if you go onto the website you’ve got to look there.
What is interesting is that there’s a lot, we don’t know what’s happened to the people that scheduled the testing, whether they were successful in doing it or not, and also there’s a good deal of doubt here about what testing, N/A, didn’t answer the question, so there’s a pretty big lump of people here who didn’t know really what we were talking about or what they were talking about. And I would like to add that PAHCOM with 3200 members represents a fairly unique slice of the office managers in this country. These office managers presumably are more sophisticated because they joined a professional association than the run of the mill office manager and by extrapolation I would say probably their practices are more sophisticated and more likely to have initiated testing than the run of the mill practice.
So in conclusion I’d say one, the practices have started the first steps towards transactions compliance. I don’t think that probably most of them have taken the follow-up steps. With privacy behind them I think they’re poised to be able to do all that, but they can’t do much of anything until their trading partners, particularly the vendors, are ready to go, and the experience that we’ve heard anecdotally around the country is that clearly some of those vendors are not ready to go, at least not ready to begin testing with practices. We know from the Y2K and the privacy experience that they will wait until the last minute, maybe not the last minute but they’re going to wait late to begin this kind of implementation, and the more uncertainty there is about what they’re supposed to do and what the vendors readiness are, the more likely that is to reinforce their tendency to delay.
I think we all have to work together to bring them around, educate them, to prod them, I think that is particularly difficult if we don’t have a clear-cut plan of action and a clear-cut set of steps, I’m prepared within my association and using my center to begin lobbying them pretty hard to get going with testing. But I’ll tell you that having checked around a little bit to get ready for this presentation, I feel like I’m getting mixed signals and I’m not really so certain what I should be telling them to do because I’m hearing that maybe we’re not ready yet for the practices to get in and start testing, that maybe the vendors have to be working with the payers first before that’s possible. Any uncertainty like that is likely to lead us into real trouble later on because they cannot wait until the last possible minute and get away with it this time or we could very well have the so-called train wreck that has been talked about before.
Thank you very much. Should I try to take questions?
DR. COHN: Wes, do you want to present your information and then if we have a couple minutes we’ll talk about what you --
MR. RISHEL: While we switch computers you might be able to get a question in.
MR. HOUSTON: I have a question. Is there an overall demographic in terms of the practice size versus level of compliance from what you’ve been able to gather from the surveys and the like?
MR. CUNNINGHAM: I don’t think we’ve got any data that’s anywhere closely, anywhere near sophisticated enough to answer that question.
MR. HOUSTON: That’s probably, to me it’s very important to determine whether it’s the large practices who are the more sophisticated practices are readily able to comply or are trying to comply versus the smaller practices who maybe aren’t doing much at all, and again, how those statistics are based upon that demographic.
MR. CUNNINGHAM: I think it’s an excellent question but I don’t, I’m very tempted to say it’s the small practices that aren’t into it yet in part because those office managers are still buried trying to, they’ve just taken the first gasp of air after coming up from privacy. And I talked to one who’s a fairly sophisticated one in Texas recently and she said testing, you mean I’ve got to test? I was told that I was supposed to wait, that this is all going on amongst the vendors and the health plans. And I’m saying don’t wait because you need to find out if they’re not ready to test yet when they are going to be ready, and she said ok, I’m on the phone and away she went. These are folks that as I was trying to paint in that setting, they don’t have a lot of time to be investing in this sort of thing, so they’re probably lagging behind whereas in the big practices or institutions you would have systems managers, you may have MBA’s, people that can spend some staff time on this question.
DR. COHN: Well, Carl, thanks and we’ll continue obviously with the discussion. Wes, thank you for joining us.
Agenda Item: Compliance Readiness Update: What We Know So Far - Mr. Rishel
MR. RISHEL: Thanks for having me here today. I’m going to describe a survey that Gartner has been conducting periodically. Characteristic of this particular survey is it’s done by Gregs Anderson which is an independent survey part of Gartner, does literally hundreds of surveys a year of this nature. Unlike most surveys that you’ve heard about this is a random sample, that is we took a profile of organization type and size and then drew randomly from published lists a structured sample that matched the underlying population. And then we engaged with that practice or integrated delivery network or health plan to sample them repeatedly over a period of several years because you get better statistical results about change if you go back to the same sample then if you draw a different sample each time. In the sample there are no physicians practices under 30 physicians because in the year 2000 when we were setting this up we couldn’t find anybody in any of those practices who knew what HIPAA was. As I said we only would accept a practice if we could talk to the person who was responsible for compliance, and it was a three year commitment.
The model from which the questions are constructed divide HIPAA preparation into five levels, the first level is just becoming aware, the second level is doing a risk assessment gap analysis, the third level is the detailed planning that it takes to do an implementation of this nature. The fourth is actually doing the work and the fifth is testing and rolling out education in the case of privacy or the various kinds of activities that go into implementing all that work that you created at level four.
This is a very busy diagram, it contains the answers to a lot of questions. You should have a handout that includes each of these pages and some explanatory information at the bottom. I brought color this morning so if you’re having any difficulty with the black and white version get a copy of the color version. Remembering that level three was planning, the general sweep of these questions leads us to believe that a whole lot of payers and even more providers were not done with the planning as of late February, early March of this year. Now what I’m going to show you is that the planning is sometimes not as far along as the next step implementing, and we did some digging to understand why that was. And as near as we can tell what’s going on in a number of settings is you go write the code, you go figure out what the client wants, that is there’s a sort of an emergency mentality that often leads to considerable rework at implementation time because they have not completed the gap analysis before they started working on remediation.
We’re also finding that in large practices, integrated delivery networks and in the more complex health plans, you have to be sure to ask how far along is your last application rather than your first application because very often they can report that they are in testing. But that’s only one application for one transaction versus the whole thing, so it’s easy to generate optimistic data depending on how careful you are in asking the questions.
Just to explain the graphic here, the large bars represent the current data for have they completed this particular part of level three. The smaller bars represent what they told us last August to the left, and the smaller bars to the right indicate what they’re doing, for Jeff I’m going to do a real quick summary of these numbers. What we’re seeing is executive mechanism for monitoring progress, only 60 percent of health plans had said they had done that, but 88 percent said they are working on it. Just to illustrate a point, that’s project management 101, that’s something that for six weeks before privacy and seven and a half months before transactions to have organizations come back and say they’re working on it strikes us as an indicator that we’re not getting that good data about the rest of it because they don’t necessarily all have the monitoring in place, but it’s an indication of where the industry is we think.
The detailed implementation plan, 55 percent of providers and 39 percent, I’m sorry, 55 percent of health plans and 39 percent of providers said they had done that. Almost all of them said they’re working on it. Application specific decisions, a little bit lower for the providers, otherwise the same. Yet all vendor contractual commitments, 23 percent of health plans and 12 percent of providers said they had completed that step, but there’s a huge amount that are currently working on it. The impression I have from this data is if we had gotten these survey results a year ago we’d be in great shape. Now, though, if these preliminary steps are not done. One area that’s interesting in this is that the number of reporting entities that said they had completed the cost benefit analysis actually went down, particularly on the provider space. And what we think is that increasingly they are not regarding it as an investment that has a return, they’re regarding it as a mandate instead. We preach the opposite, but we’re no more effective than anyone else I guess in that.
And now talking about levels four and five, level four is the actual doing the work of HIPAA remediation, level five is rolling it out, implementing it, testing with trading partners and so forth. Surprisingly for this being late February, early March, only 68 percent of health plans and 61 percent of providers indicated they’d identified the employee training methodology, which is a senaquanone(?) for privacy. Reassign need to know classifications were down at 28 and 27 percent, however, we think that in that case many organizations felt they already had job classifications in place so they didn’t necessarily need to reassign them to meet privacy.
MR. BLAIR: Wes, just so my mindset’s correct, this is data that we got from February?
MR. RISHEL: Late February, early March. Implemented system changes interfaces and conversions, eight percent of health plans and two percent of providers said they were done with that as of this February and March date. Now we asked two questions, have you begun and are you done, and this gets to that issue of the difference between the poster child system in an organization and all of the systems in the organizations. The numbers for having started were very high, 94 percent of health plans and 77 percent of providers. There’s some other questions about essentially privacy related activities, patient information disclosure, creating a trust, completed was 32 percent for health plans and 29 percent for providers. All these by the way show progress from before, it’s just measuring them against the April 14th deadline that was surprising. Implemented some particular things around security, very low responses, but that’s consistent with the timing for the security regulations.
We asked them specifically transaction by transaction how they were doing testing internally and externally, and again, what we found is that the claim has fairly high levels of internal testing, 78 percent for health plans and 66 percent for providers, I’m sorry I’m reading this wrong, 52 percent for providers. External testing, 67 percent of providers said they had found a trading partner to test with, and 26 percent of providers had said that they had found something to test with. Remittance advice numbers were somewhat lower, eligibility almost the same as remittance advice, claims status lower again, referrals lower than that. There were higher numbers for the premium payment and enrollment/ disenrollment and another thing that was interesting is we got substantive reports from providers on these transactions, 14 percent of providers said they’d begun internal testing of premium payment and 31 percent of providers say that they had begun internal testing of enrollment/disenrollment. This doesn’t make sense until you recognize that provider organizations are also employers, and there seems to be some interest in the provider organizations of using all this EDI stuff they’re putting in place in order to improve their personnel policies.
This chart is overall adding up the answers to the different questions for the different levels. It shows a start and finish for all the levels up through four, which was actually doing the work, but only start for level five, and what we saw was steady progress, the finishes for level three and level four are essentially the same, which is where I get the you do the programming, you go figure out what we should be programming kind of a model of compliance. And on the average 60 percent of health plans and, I’m sorry, I’m reading that wrong, 55 percent of health plans and 48 percent of providers said they had started the level four activities or that percentage of each of the questions answered is what they answered.
Now we also looked at the best respondents in the sample and said how are they doing. They were across the board finished through level three and 85 percent done with level four, and all of the best providers had started level five, the actual implementation or testing steps. So it’s quite possible to hear the new stories about those organizations or hear about them and get a picture that’s more optimistic than what you would get if you truly sampled the population at random.
We asked them specifically are they getting started on testing, that is have they heard from a trading partner that they’re ready to test. We broke the answers up into none have contacted me, only a few leading edge trading partners, less than ten percent of my trading partners, ten to 49 percent, or 50 percent or more. And we divided the answers according to payer and provider and of annual revenue of less than a billion or greater than a billion. And what we found is pretty much across the board, 55 to 61 percent said less than ten percent of my trading partners have been in contact with me, anywhere from an average of ten percent roughly say no one has contacted me yet except for providers under a billion dollars a year, which said that 24 percent had not contacted.
Now we lay this number out against what has to happen by implementation time, which is that the updates to the provider systems will go in, will be tested at leading edge sites, problems will be found, corrections will be made, corrections will be distributed, more providers will be able to test after that cycle. And we add that with anecdotal information we’ve heard from a number of sources that say that the testing that is going on is showing moderately good results in terms of conformance to the format of the standard, but relatively poor results when it comes to having all the data present that might be necessary to get paid. So it’s the old statement that design and coding takes 90 percent of a project and then testing takes the other 90 percent, and we think that we’re still just barely into that testing that is the other 90 percent.
So I’ll be glad to take questions if there’s time.
DR. COHN: I guess lets take a question or two and then we’ll obviously break. Steve Steindel?
DR. STEINDEL: Wes, I was looking at the demographics of this survey and it’s basically as was referred to earlier appears to be high end providers, large facilities, large hospitals, large provider organizations. Can you do any extrapolation to those that don’t fall in those categories?
MR. RISHEL: No, I think that it would be an error to look at this data and extrapolate down to the kind of practices that Carl described because of the vastly different IT resourcing and culture there. I would say that we did have representative samples of practices with only 30 physicians, which compared to the average practice is large but compared to the average integrated delivery network is still a small piece.
DR. COHN: Maybe I’ll ask this as sort of a follow-up and maybe Carl can help us with this one. The real question as I was looking at Carl’s data had to do with the issue of the impact of billing services for small providers, since there’s a certain number that are doing things a lot in paper or a lot internally and then shipping things over to a billing service, sort of almost a pre-clearinghouse sort of environment for formatting and then sending to the payer. What sort of impact does that have on the small and medium sized provider? What percentage do you think are really using billing services and is this why we’re seeing a number of them N/A, not applicable, is this something that’s going to be sort of the savior for a lot of the small providers?
MR. CUNNINGHAM: I think in general practices don’t use billing services but there certainly is a significant share of them that do, and the question really becomes how ready are the billing services. We actually kind of recommend that they don’t use billing services if they’ve got the capability of doing it themselves because it’s an extra expense and probably the billing services in general are not as aggressive about trying to collect that last penny as Mary is down there in your billing department of the small practice. So I don’t know what the percentages are and I wouldn’t hazard a guess. I was told, however, in upstate New York that one of the reasons we were worried about this show of hands that was done up there was that in that particular area it turns out that there’s some very good billing services and a lot of the small practices have chosen to use them, but the problem is that you get a different pattern all over the country and I don’t think anybody, I certainly don’t have data to show what it might be an overall average.
DR. COHN: Ok, thank you. Other questions, Kepa?
DR. ZUBELDIA: This is more for Carl, but also for Wes. What can be done to motivate the providers to test? A lot of them don’t have the technical resources and obviously they need their vendors or clearinghouses’ assistance to test. But what can be done to help them get going before the last minute?
MR. CUNNINGHAM: I think more than anything else what they need is a very, very clear picture of what they need to do and a very, very clear message coming from everybody else, and probably what they need is to have the payers going to them, having their vendors going to them, and having us lobby them like crazy. These are folks who will respond, particularly if they understand what the consequences are. The problem is how to educate them and get that information to them. The last thing that they need is the kind of fuzzy picture that I’ve encountered in the last week or so trying to figure out where thing stand, and I think Wes may have just helped explain it, that the testing process, if it’s one in which you start by having a few people test, and then you gradually after you do some adjustments have some more tests, and then you gradually build up to it, if I were to say to my practices now go out there and all of you, we probably have 30,000 practices, all of you hit those vendors tomorrow morning and demand that you send test claims through and that they help you do it, I think an awful lot of them would probably come back shaking their heads, totally confused. We actually have a horror story from a urology practice that tried to do that and wound up in so much trouble with one of the larger vendors of practice management systems in the country that he asked that the software be de-installed so he could keep on filing his claims. So I think a clear-cut picture and a roadmap is what motivates them.
DR. COHN: Jeff and then John.
MR. BLAIR: Help me understand a little bit what you envision is likely to happen between now and October, and I’m going to try to get at what I’m going after. I almost have the impression that many of the providers, especially the providers and small providers, tend to think of what it takes to be compliant from a very personal perspective and they’re just unaware of the fact that to be able to do the testing with all of the different entities, they haven’t thought through the time that it will take, so maybe they’ve underestimated how much time the testing will take and they figure that this can be done in a couple of weeks. They don’t realize that when they do that not only will they have to test with a lot of different payers but that they’re going to discover that a lot of the data elements they don’t have a process for gathering a lot of the data elements that will be needed and so we are likely to see a lot of folks in the July timeframe saying ok, we’re ready, the vendors are ready, and everybody’s ready, and in August folks will wind up starting to do this not realizing that it’s simply going to take more time than a couple of months to be able to do this. Is the scenario that I’m painting the one that you share too, or are there other pieces of this that we need to understand?
MR. CUNNINGHAM: I would share that scenario, yes, and I would go, maybe I would even trump you one by saying that they haven’t even gotten to the point yet in many cases of understanding or thinking about whether it’s going to take two weeks or two months to go through this process. They are sitting there waiting for their vendor, many, many of them, to come around and tell them ok, we got it installed now, now you need to start testing. And nobody’s coming so they’re perfectly happy to sit there and if they ask about it they’re told we’ll be compliant, don’t worry about it.
MR. BLAIR: Wes, what about your thoughts?
MR. RISHEL: I think that blandishments from the vendors is a significant issue at this point. There are a couple of questions that I don’t know the answers to that I think are important. One is how many of these small practices are currently filing on paper, because other than for Medicare they can continue to file on paper. The scenario that I think represents the worst case scenario is that rigid enforcement of the October 16th deadline leads to a situation where practices wake up and realize that their vendors are not going to deliver, the lawyers get rich on lawsuits, but in the meantime the industry goes back to paper. The health plans are not able to handle that amount of paper and even the practices aren’t able to deal with that amount of paper. So there’s a reduction in the payment stream going back to providers and there’s dislocation in terms of what businesses are available and practices get acquired or go out of business, it could get to be a scenario that would have substantial repercussions to health care in the United States, and also I think substantial political repercussions on a national --
MR. BLAIR: What would you suggest would be the most constructive response of HHS to deal with this? And I’m saying that from the standpoint that Congress has basically said they’ve given us a one year extension and don’t come back and ask for another, so HHS has just a few tools to be able to help, one of them is to delay the enforcement. What are your suggestions of --
MR. RISHEL: The difficulty from a regulatory point of view is that each time you delay enforcement you create the anticipation that they’ll be more delays in enforcement. So what I think is needed is some sort of a structured response, one response might be that, a signal, and I’ve used that word signal advisedly in terms of what it means, that health plans that are ready to accept the new standard claims but continue to accept the old format electronically for some period of time would not have the hammer come down on them with regards to enforcement. That’s actually consistent with the law but inconsistent with the regulation and FAQ’s that have been provided by DHHS. What I have been advising clients is that should that happen or some similar scenario happen, that doesn’t mean oh, it’s another year, we don’t have to worry about it now until May of 2004, but to remember the relatively old joke that I’m sure everybody’s heard about two people walking in the woods that stumble on a bear and they start to run, and the one guy shouts up to the one in front and says why are you are running, you can’t outrun a bear, and the guys in front says I don’t have to outrun a bear, I have to outrun you. And recognize that as in fact their peers do become compliant their enforcement risk goes up because at some point the government simply has to make an example of those that have lagged on compliance.
DR. COHN: John, last question and then we’ll break.
MR. HOUSTON: Is there, to be totally pragmatic about the issue, is there enough capacity from the vendor side to even accommodate all the testing? It sounds like it has to be crammed into the next five months.
MR. RISHEL: I don’t believe so, I have not directly asked that question. I did do a survey of the vendors of the top 40 practice management systems, recognizing that there are about 2,000 such products out there according to some numbers I’ve heard, but the ones I talked to are the ones that had bigger presence in the industry. And what I got was quite a variety of different responses, some of which were recognized as blandishments, just yes, we’ve got some software out there, we’ve begun testing, we have no problem with capacity, but what that says is they don’t have enough people that requesting to test yet to generate a backlog.
DR. COHN: Well, I really want to thank our presenters, I think you created a great segue into the next discussions, which is the WEDI comments around really what I consider to be transition planning and other comments, I know Carl you’ll be joining us I think for the reactor panel. With that obviously thank you very much. We’ll take about a ten minute break, try to get back towards schedule, and thank you.
[Brief break.]
DR. COHN: Will you please be seated? I think we had a very interesting first session and obviously we’re looking forward to the presentation by WEDI. I see in our agenda it’s really called the WEDI HIPAA contingency planning proposal, I’m not sure I consider it to be contingency planning as much as transition planning, but obviously we can talk about that. Ed Jones, I think you’re going to be, as chair of WEDI you’re going to be leading off the discussion as I understand IT.
Agenda Item: Overview of WEDI HIPAA Contingency Planning Proposal - Mr. Jones
MR. JONES: Thanks Simon. I’m Ed Jones, the chair of the Workgroup for Electronic Data Interchange, known as WEDI. To my right is Steve Lazarus, who’s the immediate past chair of WEDI, and to my left is Dave Miller who was the director of the task group that the board put together to look at contingency planning/transitional issues to ensure compliance. Dave in just a second is going to give a brief overview of a letter that reflected WEDI Board policy, it went through quite a bit of review. As you may know WEDI is a representative body, our board has I believe 31 members representing stakeholders across the health care spectrum, and we have well over 6500 people who participate in the WEDI Strategic National Implementation Process Initiative, which relates to addressing HIPAA issues and implementation issues.
The outcome of our deliberations on contingency are reflected in the April 15th letter that WEDI sent to Secretary Thompson on contingency and transitional issues, and I’d now like to turn it over to Dave Miller who’s going to synopsize that for you.
MR. MILLER: Thank you very much. I’d like to start with a little background on the development of the workgroup, because I think it’s pertinent to one of the key issues which is timing. The workgroup was formed in early February with a great deal of concern from the WEDI Board of Directors that we were indeed facing a serious problem with implementation of the transaction code set in October. Driven particularly by the fact that everybody had to convert to the 4010 A-1 version that had just been recently released, and second, because ASCA expires in October and requires the Medicare providers to submit electronically and can’t use the paper form, except for small providers that exception.
So we took a look at that issue and began to form some concepts around what the problem was and how we might be able to resolve it. The first issue we faced was gathering information, and as you can hear from the speakers this morning that has been very difficult. We looked at that and determined that to be honest with you there wasn’t sufficient time to determine exactly the preparedness of the providers, and it was unlikely that we could accomplish that task prior to even a late August or September, come up with a conclusion that in fact there would be a train wreck. We decided very early on that we would not spend the time or effort determining the exact preparedness of the covered entities, but concentrate more on what if the covered entities were not compliant.
Second, I would point out that we sensed from the information we had that there were a large number of covered entities that were going to be prepared. Those numbers ranged anywhere from 40 to 60 percent. I think Wes’s information supports that in theory. So we knew that the potential for a number of covered entities was very large, particularly amongst providers, and we became concerned that the impact on the industry would be great even if the degree to which compliance was succeeded was five percent. We needed 95 percent or more to be compliant or there was going to be a very large impact on the industry.
So with that we began to look at alternatives and the first issue that we faced was the data content issue. The format issue is certainly a complex one, the ANSI format is difficult and the vendors have had difficulty transitioning to it. But more so we were concerned on content because as was stated earlier there are some of the elements that providers were not familiar with collecting before and even though they could go through a clearinghouse to achieve compliance to convert to the format, the issue of having some of those data elements not available to them was a concern.
We focused our first recommendation on that particular aspect. The second one is related to the fact that we knew a large number of covered entities would be able to receive the transactions, but at the same time there was the likelihood that some covered entities would not, particularly for example, a provider would not be able to send a transaction at all, not prepared to go through a clearinghouse, had been familiar with using the NSF or UB format prior to that, and would not have a way to convert to the format in time, leading them to deliver a paper claim transaction, and we felt that that was going to be a significant impact both to the provider and to the payer causing not only increased administrative expense but delay in processing.
Compounded by the problem of anticipating that, and the task of preparing for it without firm hard facts as to what type of volume of paper was going to occur, we speculated that payers would not be able to anticipate growing sizes of mail operations and/or keying operations. That scenario led us to the second recommendation which said a covered entity who was compliant could accept or continue to accept the non-standard transaction communication rather than go back to paper until such time, or for a short period of time, until such time as the covered entity was prepared. And you could use the example in either case, whether it would be a provider continuing an NSF input and/or a payer who was unable to comply with the 835 transaction in its current form, could continue to use a non-standard communication.
Those are the essence of the two recommendations that we made in our letter of April 15th. And again, the committee completed its work approximately end of March, came to consensus on the exact wording slightly before the 15th and we asked the Secretary to give us a response within 60 days because we felt that if we didn’t have a resolution to this problem by mid-June it would be very difficult to get that communicated to the community and would not allow them to prepare for implementation by October.
And with that I would think we’d entertain any questions.
MR. LAZARUS: Let me just make a couple of comments before we do that. This issue is more complicated than just getting claims in the right format and getting them processed. We have a family of transactions, although emphasis appropriately is being placed on the claims data, there are other transactions that are currently going on in different electronic formats or paper and phone formats today that are also required to be supportive of the legislation and the regulations. An example one of our board member raised was that they will be prepared and they’re already testing for the 837 to be submitted, it’s a large hospital organizations. They got so many payers across the country they’re dealing with it’s going to take them quite a while to get that done, and they’re not going to be ready to process the coordination of benefits 837 version until after October 16th even though they’re working very diligently to get the basic transaction completed. So don’t want that lost, this is not just claims, there are a lot of other transactions the industry has to deal with as well, and the policies that we recommended here would allow for the transition to all of these.
And secondly to point out, we used the word brief in describing the length of this transition, and we debated a little bit about what timeframe that meant and didn’t come up with a consensus answer but it doesn’t mean a year, it’s something shorter than a year. I think that’s an important message also, that this is not to be a year and then another year and then another year, keep going like this, the intent here is to provide a smooth transition process over a brief period of time that will allow us to get through this testing and implementation process and we’re not looking for something that would permit those who have delayed doing anything from continuing to do a delayed process for the six months or year before they start working on this effort.
MR. JONES: I want to reiterate in this request for guidance from the Department that we were stressing in here this would relate to those who are making, have made, good faith efforts to achieve compliance and for, I think we have an example in here of one large clearinghouse that was having difficulty getting testing going with many of its payer clients so this is a very large industry, very complex industry with a lot of relationships. If you take an individual provider many payer relationships and if you take a payer many provider relationships, and I think when we crafted this going back into the ‘90’s we really looked at more or less of a bilateral flows between payer and providers, it’s much more complicated. So again, I want to emphasize that this is focusing on those who are making good faith efforts to be compliant within a brief short period of time.
DR. COHN: Questions from the Committee?
DR. ZUBELDIA: I would like to have a clarification. On your second recommendation where it says permitting compliant covered entities to establish a brief transition period to continue utilizing their current electronic transactions in lieu of reversion to paper. You’re talking about payers, right?
MR. MILLER: It would be typical that that would be the case but I think we could make examples where providers would, this is an example of a covered, client covered entity that is a provider, not being able to receive a standard 835 transaction from a payer and establishing a brief period of time in which they would accept a non-standard communication.
DR. ZUBELDIA: Is this only for compliant covered entities? So they would have to somehow demonstrate compliance first before falling into this exception? Or how are you planning to address the flat out non-compliant covered entities?
MR. MILLER: WEDI did not attempt to assume that we could change the law, the law is in effect October 16th. Entities who are non-compliant, unable to produce or receive the standard transactions are in violation of the regulation. Given the Secretary has authority to enforce the regulation it’s not up to the covered entities to perform that task. However, this exception allows a covered entity that is compliant to determine whether they choose or wish to accept the paper claim transaction, for example, rather than a non-standard. We’ve heard from some who’ve said I’m not prepared to operate a dual path, and if they’re not prepared to operate a dual path and if the provider is unable to submit a standard transaction then there is no choice but to convert to paper or be again non-compliant. So we’re trying to avoid the reversion to paper for that particular situation.
DR. COHN: David, maybe you can help clarify this for me, because I’m, and once again maybe I just need to hear this from you. As I look at this letter and the proposal I think there’s an underlying assumption that all payers will be able to accept HIPAA compliant transactions on the compliance date in October. Is that your view? Do you believe that that’s going to be the case?
MR. MILLER: The committee came to an opinion that a large number of providers would, or a large number of payers would be compliant because of competitive market forces. But we did not assume they would all be.
MR. BLAIR: Is the same true for clearinghouses?
MR. MILLER: The same is true for clearinghouses, although to a lesser degree.
MR. LAZARUS: Now there’s an accompanying document that indicates what some of the scenarios might be for those who are not compliant, including using a clearinghouse to be their interface if you will, that accompanied the letter. And those are all permitted options under the current regulations as to how one might address the issue.
MR. JONES: We and others have made efforts, we’ve certainly done it through the WEDI-SNIP activities and I know CMS has had initiatives on the educational front. It’s again just an enormous educational challenge to get this information out to all parties and we still have that challenge moving forward.
MR. MILLER: I think one of the assumptions that we did make was that it was highly unlikely, the probability of 100 percent of covered entities being compliant exactly on the 16th was very low. The assumption being that if 60 percent of them were compliant, that would be good, and over a period of time that number would increase. What we wanted to avoid was having those entities who have spent the time and effort to comply to also be if you will penalized by the inability of their trading partner to comply. The impact of the administrative expense of in either direction converting back to paper because the compliant covered entity was not able to accept the transaction, and would in fact be forced to reject the transaction.
DR. COHN: Right, I think just having looked at your background document again I’m still reminded that the actual recommendations you have really are with the assumption that most if not all of the payers will be, and that the other recommendations made for if payers were not compliant really are not addressed in the type of recommendations you’re making, which is probably appropriate, but once again, this is really meant to help providers get electronic transaction to a payer. Kepa did you have a comment, and then Mike.
DR. ZUBELDIA: How specific is the first recommendation on the letter of what it says where it says that standard transactions may not contain all required data elements? Is that specifically what you want or is an example, because I understand that there may be some payers or clearinghouses that may need additional data elements above and beyond what’s in the standard transaction in order for the system to work properly. Is that an acceptable recommendation or it’s only the recommendation that required data elements may be missing? How about situation on data elements?
MR. MILLER: Let me address the first part, the required elements. There is an influence by state regulation to comply with clean claim laws, and HIPAA has required fields that all of the covered entities are attempting to build into their conversion processes. We know from testing that there are transactions that we’re currently receiving and testing that do not contain a required element, and yet HIPAA also does not require the covered entity receiving the transaction obviously claim to payer to utilize that information to make a decision regarding the claim. So where a clean claim law regulation requires us to accept a minimum amount of data, and we are in fact able to adjudicate the claim to payment, we find that a reasonable approach to receiving the HIPAA transaction in the 4010 A-1 format. The committee did not address the alternative issue that you have, but again, the ANSI guide specifies what the requirement is on the situational, and this does, this recommendation was intended to give the market forces the opportunity to determine whether or not they could accept that transaction where required by state law to accept that transaction, and if not they may need in fact to either reject the transaction or request the additional information separately.
DR. FITZMAURICE: This is a very large step for the industry to take and even though it’s been announced since 1966 there’s some things that strike me that it seems to me in order of being close to compliance at this time it would be payers, health plans, clearinghouses, vendors and providers, although vendors are not generally covered entities. People talk about the vendor response and the competitive marketplace, and it would seem to me that if there is a change coming and if people think that it really is coming, that you have a competitive advantage by being there first and announcing that you’re there first. I don’t see that happening so much in the vendor response. There is a lack of testing and people say it’s because of lack of information, and I’m wondering well, HIPAA had deadlines, is it that the deadlines are not seriously taken or that it’s more complex than people thought and needs more coordination than people thought in the past five years. One thing that does strike me is that it is more complex. So my question is about the incentives operating that we’re in this situation now, and we still have time before October 16th, but we do you see the incentives are operating on the covered entity actors, and how do they operate over time for improve efficiency in HIPAA transactions? That is is the announcement effect by the government influencing their actions? Did this sense of intensity not occur a year ago because people really weren’t sure that there was some seriousness about it? Or that they were reluctant budget and spend money until they got serious about it, until deadlines really came approaching? And then I’m looking for lessons to be learned in the future about working with the industry and cooperating to get them to someplace where we have more uniformity or standardization and some efficiencies.
MR. MILLER: If I interpreted your question correctly, and I’ll allow Ed and Steve to also think about the answer to that because it’s quite complex, let me try it this way. Being from a payer organization I can certainly address the competitive nature, I may not be able to speak to the same degree to the clearinghouses. The committee did address the subject of the market forces and the issues related to providers, so let me start with payers.
I’ve been involved in answering inquiries to the company on our preparedness for HIPAA, and I would say not a week goes by that we did not get either a request for proposal survey or an inquiry from one of our existing customers with a laundry list of HIPAA transactions standard code questions. We became aware that this was in fact a competitive advantage to be prepared to implement HIPAA, we were also understanding that some of the health plans were not at the same level of preparedness as we may have been. It became obvious that the market force to drive a health plan to become compliant was very strong.
On the clearinghouse side, it’s somewhat of a different picture although all of them are obviously interested in transaction volume, that’s a key driver for the clearinghouse. It’s necessary for them to maintain that transaction volume and anytime another competitor can take that away because they’re compliant is certainly a market force. However, providers are not as, providers are perhaps reluctant to switch clearinghouses in midstream and so that force isn’t driven whereas our customers may or may not choose to purchase our products because we are not compliant. So I would say that the clearinghouses to a lesser degree have been driven between each other for the competitive reasons.
On the provider side, I can’t answer that question specifically, I have no information on it, but I would speculate that providers between each other are not as interested in their compliance to the standard, they have other issues they’re concerned with.
MR. JONES: I think all of the factors that you mentioned are in some way having a positive or a negative slight or major impact on where we are. I take the view, having looked at the provider side, although I come out of the payer community I’ve spent quite a bit of time on the provider side particularly with small providers, I’m really amazed we’ve made as much progress as we have in the privacy area, and certain given the complexities in the electronic transaction arena I think where we are is really remarkable for a $1.5 trillion dollar industry with lots of players and lots of inter relationships. So I think we’ve actually made progress here and I think the curve of that process is going to continue to turn up, particularly as we get close to that deadline. So I think the document in our work reflects we just want to make sure that there are risks around the 16th of October and our role really was to request guidance on how the industry should deal with those risks.
MR. LAZARUS: Responses to your questions about what the market forces are going on here, health care is a complex issue as you’ve indicated. Our company’s done some work in the state and county government arena where there is significant budget problems, even though people know what the right thing is to do they don’t have the resources to do it, and that’s contributing both, some of those organizations are both providers and payers working in this environment, so that’s an issue that’s contributing to why are we not all ready now. I think that the addendum being published on February 20th instead of last year had an impact on where we are today because many vendors didn’t ship out their final upgrades until that was finalized, or providers and health plans didn’t want to implement those final changes until they knew that was a final this is what we’re going to be doing. So during the course of October, November, December, January that had an impact in less getting done than would have normally gotten done perhaps.
In terms of this testing complexity issue, something that SNIP realized over two and a half years ago and developed a sequencing plan and this concept of certification with third parties to try to reduce the amount of point to point testing that was going on, so there’s been a lot of industry collaboration, I’m trying to figure out how to minimize, not reduce completely, but minimize the amount of work involved in getting through the testing phase, it’s still substantial and important but there’s been some strategic things launched in that area to help with that process.
And then we have this issue of the return on investment, which is what drove WEDI in 1993 to recommend that we have administrative simplification. Many of the organizations today, especially on the provider side, I can’t speak so much for the payers because I don’t do as much work in that field, view this today as a compliance issue, not as a business investment issue because it’s associated with privacy and because they’re forced to do it, because, because, because, and we have not done perhaps a good enough job of selling and displaying what the real financial benefits are long term to the whole industry. If you want a lesson learned about what we could have done better or differently that’s probably a good place to think about it as well.
DR. COHN: Well thank you. I think to try to keep some semblance of our agenda I think we need to move on to our first panel, which is really the provider reactor panel, so Carl you’re there, I think we need to do a shifting of seats here if we could. I think we have Carl Cunningham, George Arges, and Robert Tennant, maybe they can take your spots, obviously we would like you to stick around to sort of provide clarification and input as we discuss these. Carl Cunningham I think you’re on, up first again, are you comfortable in that position?
Agenda Item: Provider Reactor Panel - Mr. Cunningham
MR. CUNNINGHAM: I think I’ve laid out already for you substantially what I think that setting looks like and I think it’s fair to say that in our estimate the limited internal resources, little understanding of the technical task, trading partners that may or may not be ready to start testing, and only five months remaining, there’s a fairly high risk that we’re going to have some of our practices miss the testing deadline. Now if that were to happen on a widespread basis there could be just because of the delays themselves, severe testing log jam as the deadline approaches. And that can make it virtually impossible for some of these practices to comply.
If you then, because they’ve missed that deadline, cut off the payment of claims, there could be some fairly disastrous consequences that follow. Particularly a small practice cannot handle a disruption in cash flow without very quickly slipping into an insolvency situation. Those recurring payrolls that come around every two weeks are very, very unforgiving and all the other expenses that they have to pay, and they’ve got no reserves to fall back on. Moreover if you wait until very late and you start testing and guess what happens if you discover that your practice management system cannot in fact be made compliant. Because there are a lot of systems out there, and some of them are little regional systems that were invented practically in somebody’s garage, and they may not become compliant. If you encounter that situation it’s entirely likely that it would take several weeks, if not months, to be able to replace that system.
Now it would be fairly easy probably to fix the blame on the practices own procrastination, I think that would probably be both unfair and irresponsible because some of those delays may result from vendors and health plans inability to test from the confusion that’s going on, and also the end result is that no matter who else messes up it’s going to be the provider that winds up paying the most severe price of all if that cash flow is disrupted.
And finally, of course, there are severe potential systemic consequences that WEDI has outlined. And all this folks is not a natural disaster or something like Y2K that was put in place decades ago and that we all didn’t ever think we’d get to this point. I mean this all is very much the result of a conscious federal government decision and it is something over which HHS exercises discretionary control.
So the American College of Physicians therefore strongly agrees with WEDI’s assessment that there are potential serious and unintended adverse consequences. We also agree that HHS should endeavor to ameliorate those potential consequences, and we agree that both courses of action that WEDI has recommended are appropriate and should be adopted. I’d like to emphasize though that we urge that both of them be adopted. I wasn’t sure from the WEDI proposal whether they’re talking about an either/or or both but we would certainly emphasize the importance of adopting them both because you’re going to have practices that fall into both categories and other providers as well, and it would be a mistake to miss them because they didn’t happen to fall into the chosen category.
In support of those recommendations I can tell you that we are committed to doing everything possible to education, assist, and encourage our members to meet that October 16th deadline, and we expect that a very large percentage of them will do so. It’s the others that we worry about. I’d also clarify that we understand the short transition period to be intended not as a general extension and I think that was made clear by WEDI as well, but as rather providing the flexibility that is needed in order to be able to allow the health plans to continue payment during that transition period when people are trying to comply but haven’t been able to quite succeed in doing it.
There are a couple of modifications that I’d like to recommend be made to the WEDI proposal, assuming that they weren’t envisioned already. First of all, and most important I think, is that, well maybe not the most important, both are important, is to link the claims payment cutoffs to the enforcement process. HHS has announced and has been following a very reasonable and progressive enforcement process on privacy and intend to do so on transactions as well. It seems very logical to me that payment should continue so long as the enforcement process is going on, so that if a practice is found to be willfully rejecting implementing, sure, you’re going to hit them with penalties and you probably should cut off payment. But if you go to them and say you’re out of compliance, you need to get in compliance and here’s what you need to do and the practice says ok, we’ll do that, and there’s an agreement as to what the steps will be, then as long as the practice is continuing to meet those steps then the cash flow should continue for the payment.
The second recommendation we would make is that the WEDI recommended provisions also be applied to Medicare. Medicare payments represent about 40 percent of the receipts of most internal medicine and general internal medicine practices, and if those were cut off the consequences would be a devastating blow to the practice, and their recourses that might otherwise be available with regard to health plans would be maybe to go back to paper claims. But the Administrative Simplification Compliance Act cuts them off at the pass apparently and says no, if you’re above a small size, you’re going to have to file electronically. And we really need some clarification as to what that waiver is going to amount to, who it applies to, how it applies and how a small practice goes about getting it. But even for the small practices that might be eligible for the waiver and would be allowed to submit paper claims I think it’s very clear that Medicare intermediaries are no more equipped to handle an avalanche of paper claims than are the commercial carriers. So that really isn’t going to get us around the problem. So I think it’s very important that the provisions that WEDI is talking about should be applied as well to Medicare.
And I think with that I would stop and turn it over to our next speaker.
Agenda Item: Provider Reactor Panel - Mr. Arges
MR. ARGES: Thank you, my name is George Arges, I’m the senior director of the Health Data Management Group at the American Hospital Association. On behalf of our nearly 5,000 member hospitals, health systems, networks, and other providers of care I’d like to thank the Subcommittee today for the opportunity to present providers concerns around the implementation and to propose to you an AHA plan for contingency.
Without a doubt hospitals greatest concerns regarding implementing the HIPAA transaction standards are the enormous harm that could occur if there is a disruption to the existing claim submission and payment cycles. The potential for payment disruptions is real, all it would take is poor, improper, or incomplete implementation of the transactions standards. Because hospitals do not tend to have large cash reserves, adverse changes in cash flow could create disruptions to patient care. The possibility of even the slightest operational breakdown or system failures in the post HIPAA implementation period therefore cannot be ignored or dismissed. Therefore we believe that CMS needs to focus immediately on developing a system wide implementation plan that clearly outlines the correction action that every health plan must be ready to execute to ensure adequate cash flow to providers. In addition, completion to full end to end testing of the transaction standards well before the October compliance date would complement this comprehensive implementation plan and go a long way toward alleviating providers concerns about operational and payment disruptions that might occur as a result of implementing the transaction standards.
Hospitals are working hard to meet the transactions implementation schedule and many are using testing and certification software to help them validate their ability to properly prepare the transaction standards. However, without end to end testing, it is impossible for hospitals to be absolutely certain about how a specific health plan will use each of their required situational elements. This problem largely results from the ambiguity of situational data and how they are applied by various health plans. Frequently the reporting of the situationally defined data is specific to the type of service, the category of provider, and the different health plan benefit coverage requirements, just a few of the items that influence reporting variations. Without end to end testing providers will not have a complete understanding of how health plans utilize a particular data element within the transaction standards.
Providers are eager to conduct end to end testing with real world examples to ensure that they have properly interpreted the reporting requirements of the standard transactions and that they are capable of exchanging the standardized information electronically with the health plans. To date most providers remain in the dark about the health plans testing and certification strategies and ultimately the dates for full implementation of the transaction standards. Hospitals are frustrated by the absence of information about whether they can conduct end to end testing with many health plans. We urge that all health plans develop and communicate a rigorous testing schedule that would include end to end testing directly with providers. Of course such testing should be concluded well in advance of the October deadline in order to give providers clear notice of and time to correct reporting and formatting deficiencies that may result in the rejection of transactions that a provider currently believes are HIPAA compliant.
Clear and open communication between the health plan provider not only during the testing phase but also after October 2003 will be essential to assure a smooth transition to the routine use of standardized transactions. Health plans will need to communicate to hospitals information that confirms the health plans receipt of the transaction and specifically identifies the deficiencies that might exist. We therefore urge CMS to recommend the routine use of various X-12 acknowledgement transactions as an adjunct to the submission of a standardized transactions.
Hospitals sincerely hope that the transition to the HIPAA standardized claim occurs smoothly and they are doing their part to ensure that smooth transition. The Department of Health and Human Services, however, must issue industry guidance to ensure that all stakeholders, health plans, and providers, are prepared for processing failures should implementation of the standards not proceed smoothly. The guidance should direct all health plans to have at the ready a comprehensive contingency plan that guarantees release of an appropriate cash flow to all providers with whom the plan does business. The plan must be easy to implement and maintain and clearly communicated to the providers in advance of the October compliance deadline.
Before going further in describing how such a contingency plan would work it is important to note that we are not in any way advocating for a delay in the October 16th compliance date. Instead we are urging the Department to establish a system wide implementation plan to assure that any unintended negative effects do not cause irreparable harm to providers operations and ultimately to their ability to provide uninterrupted quality patient care. Only real live experience in handling claims data and other transaction standards will enable health plans and providers to identify what data elements are missing so that the systems can be reprogrammed or clearinghouses can be engaged to insert all of the necessary elements the next time around.
Creating the payment cycle safety net as providers work with health plans and clearinghouses to iron out any remaining bugs in standardized processing systems would minimize the incentives for providers to abandon electronic claims submission in favor or resubmitting claims in paper format. We believe that dropping claims to paper will be counter productive, and if widespread seriously disruptive. Relying on paper claims whether as a fall back for failed claims or for all claims will only increase the administrative costs for both provider and health plans.
We believe that only HHS is in the position to provide the necessary leadership for the development of a system wide implementation plan. In our view, its failure to do so is likely to result in the transaction code set standard roll out being prematurely judged as a failure by providers and patients. Any system wide contingency plan related to the standards must be able to establish a real course of action that every health plan would adopt to prevent disruptions to the historical pre-HIPAA payment cycle. Health plans must communicate their planned course of action clearly to the providers. The communication should one, identify who individuals or departments are responsible for coordinating continuation of payment volumes and if necessary capable of intervening and applying corrective measures to restore payment volumes to pre-HIPAA levels. That would include providing contact information such as phone, fax, email or mailing address.
Secondly, it should describe the type of documentation or information if any that the provider will need to supply in order to receive emergency payment from the health plan. Today most health plans know the amount of time it takes to receive, process, and pay a claim as well as a typical transaction volume in payment totals that they handle each month. As part of its plan for contingency payment each health plan must establish certain baseline for each provider. That includes determining the average number of processed claims per day for the year prior to the transaction code set compliance deadline. And two, the average payment per day based on the transaction compliance deadline as well, the prior period. The formulas are very simple, just basically taking the claims processed for the year as a baseline, dividing it by 365 to give you the average, the same for the amount of claims paid on a daily basis.
The provider would be eligible to receive a contingency plan if any time the providers daily volume of claims processed or the daily payment received falls more than five percent below the established baseline. For any period triggering a contingency payment the health plan would adjudicate claims based on the actual data submitted, provided that the claim was submitted in the 4010 A-1 format and using the standard code sets. The claim should also include the data elements necessary to process and adjudicate the claim before the implementation period. The health plan sends a submitter a statement identifying the missing or non-material data element errors. Any provider would be eligible to receive payment under the contingency plan only so long as it takes action to use the data provided by the health plan outlined in the third item I mentioned just before. It includes the submission of a corrected mechanism, whether through the use of a clearinghouse or by reprogramming its own systems.
Again, it is important to stress that such a system wide implementation plan is not a delay, the proposed implementation plan does not help entities providers or health plans that are not completely unprepared to generate or accept a standard transaction. Rather it is an attempt to ensure that covered entities that are in substantial compliance are not inadvertently penalized for their efforts by damage to their cash flow.
The system wide implementation plan should include a timetable. With respect to covered entities that are prepared to use the transaction and code sets as of the compliance date HHS should require use of contingency payments with respect to every provider in the health plan for the first six months after the compliance date. Thereafter HHS should use this enforcement discretion to ensure that any individual health plan or provider that continues to have regularly occurring contingency triggering events is addressing deficiencies.
Additionally, health plans that receive claims that contain material deficiencies should as a matter of improving the application of future electronic transactions communicate to the provider the specific problems in need of correction. Continuing to use non-standard electronic transactions is wasteful, counter productive and contrary to what Congress intended when it mandated adoption of the transaction standard. It only prolongs today’s administrative inefficiencies. However, implementing the transaction standards requires the reporting of many new data, more than many health plans today require or actually need for adjudication of a claim. We have heard from providers that in the course of testing the standardized transactions some health plans have adopted so stringent an interpretation of the HIPAA compliance that an entire batch of claims may be returned to the provider if only one claim in that batch contains an error. Consequently as we transition to the standard world of HIPAA HHS should allow health plans to relax some of their edits to match the pre-HIPAA processing requirements.
Health plans or clearinghouses should notify the provider of any missing data elements so the provider can make the necessary corrections in future transmissions. In addition, the Department needs to issue guidance to health plans outlining whether and when it is appropriate to return an entire batch rather than just the specific defective claim. Such guidance must necessarily make a distinction between some tactical format versus data content. In the long run, it may be defensible and desirable to include the accessed content required by the implementation specifications in standard transactions. Certainly it would allow health plans coverage criteria to be far more detailed than currently is possible.
Over time, as systems are refined, programming corrected, and clearinghouses engaged, there may be relatively few claims for which a problem occurs. In the near term, however, it is not desirable or defensible to jeopardize the flow of provider revenues or to increase the administrative costs of transaction processing simply because payment and eligibility verification systems on October 16th begin to spit out rejection notices based on unspecified HIPAA defects in application. Again, it is only with real world claim testing that providers and health plans will gain the understanding that they need to perfect compliance with the transaction standards. This process will require close collaboration by providers and health plans to better understand the appropriate use of the standard data elements. In the meantime it is essential that a safety net be established to prevent catastrophic disruptions to current processing and payment cycles that might disrupt essential hospital operations and negatively affect patient care.
We urge NCVHS to recommend that CMS take immediate action to create a safety net that would enable providers and health plans to make a smooth transition to HIPAA standardized claims processing. We thank the Committee for the opportunity to present the AHA proposal for such a safety net and you will also find attached to our testimony a recent letter that we went to the Office of HIPAA Standards within CMS outlining these recommendations for moving ahead with implementation.
Thank you.
DR. COHN: Robert, before you start, I actually do want to remind both the reactors, this panel and the next one that we only have 30 minutes for the entire set of presentations and we actually did want to have an opportunity for some discussion, because obviously we do have a couple of questions we would like to ask all of you and would like to come to a conclusion during this morning’s session. Robert I do see that you also have a similarly long presentation and I’m hoping that maybe you can help us abbreviate it and make sure that you, however, it’s important that we see the key issues in your recommendations. So my apologies but obviously we’re trying to compress a lot of information and get a lot of input very quickly.
Agenda Item: Provider Reactor Panel - Mr. Tennant
MR. TENNANT: Dr. Cohn, members of the Subcommittee, the Medical Group Management Association is pleased to talk to you today on this important issue. My name is Robert Tennant, I’m senior policy advisor for MGMA, and MGMA is founded in 1926, we have 19,000 members that work in more than 11,000 group practices, in which more than 220,000 physicians practice medicine.
I want to talk today about the WEDI letter and offer some potential steps the industry can take to smooth the important transition to HIPAA. I’d like to preface my comments with a caution for us to remember the underlying goals of HIPAA, which was to improve the effective and efficiency of the health care system. Clearly there is a potential problem looming in October and I think this Committee is doing an excellent job of bringing those issues forward.
Our own recent survey done online and unscientific supports much of the survey data that we’ve heard today from Carl and Wes. Clearly providers are not ready and for the most part they are identifying their vendors as the potential problem. But also, and we’ve touched on this subject, providers have not yet identified potential missing data elements, and that is a real roadblock I think to moving forward. Certainly MGMA supports very strongly both the recommendations from the WEDI letter, it’s critical that claims continue to flow in October, and I wanted to outline a few recommendations that we have.
One is that the government get a comprehensive survey underway. We need to find out exactly what’s going on in the industry, I think we’ve heard some anecdotal evidence, some survey results, but we need to know exactly what’s going on in the industry. That will help us drive policy.
Operational compliance, where a health plan accepts a HIPAA formatted claim but not necessarily has all the data elements. As long as the claim can be adjudicated by the health plan, the health plan should be permitted to accept that claim. However, certainly there are health plans within the industry that have not the capability to handle those different types of edits, and so that requirement, that should be an option for health plans.
They should also be permitted to accept proprietary claim formats, we suggest for six months. But with that it’s important that health plans report back to providers what data they are missing because you don’t want to run into the problem after six months of providers continuing to submit non-compliant claims.
Also health plans should consider a way station. If the government is unprepared to allow a safe harbor for health plans, health plans should be able to take a non-compliant claim and keep it in a way station so they are not in non-compliance with the law, but then communicate back to the provider whatever data elements are missing, therefore the provider can get in, fill in the claim, and resubmit. As well, some health plans currently are offering clearinghouse software to their providers. This allows providers to submit a non-compliant claim to the health plans clearinghouse quickly and easily, the clearinghouse then converts is to the X-12 format and the health plan can adjudicate that claim. This should be widespread to all providers that believe they will not have the required changes in time.
Similar to the AHA we believe that interim payments to providers should be considered by those health plans who know in advance, and apparently there are many, they know in advance that they will not be compliant by October 16th. They should automatically be working to develop a method of payment that will allow these providers to continue their cash flow.
Health plans should also prepare for additional paper claims. It’s an unfortunate reality of this system that many providers are going to drop back to paper. We have not recommended that simply because with the huge deluge of paper claims there’s automatically going to be a delay in adjudication and payment of those paper claims. So while we are not recommending that, many providers are seeing that as a safety net.
However, we also believe that health plans need to prepare for a huge influx of providers trying to test at the last minute and if you just look at the number of submissions through ASCA for the model compliance form you saw an enormous number of hits on the website over the last few weeks. You can expect to see that again come this October.
Health plans who are not in compliance by October 16th should not be permitted to impose clearinghouse fees on providers submitting an X-12 formatted claim. As well, we certainly believe that there needs to be an expansion of CMS educational activities, especially aimed at providers, small and rural in particular, but also an extension of some of the outreach to vendors that CMS has undertaken over the last few months.
In conclusion, I just want to say that we’re very, very concerned about October 16th. We need to have a system that allows the continuation of cash flow and certainly MGMA and other provider organizations are working hard to educate providers but we’re at the mercy, of course, of our trading partners.
I’ll stop there and entertain any questions.
DR. COHN: Thank you for your understanding in terms of abbreviating your comments. I think we have time for one or two questions before we move to the next panel. Kepa?
DR. ZUBELDIA: Obviously the goal here is not to test, the goal is to get paid, there’s a significant difference. In those that have tested do you have a sense for what has the result been? Has the result been that they tested clean and they can get paid? Or has the result been that when they test they have to go back to the drawing board and apply some more remediation steps? Because that would also have a significant impact on the outcome. And I have a follow-up on the testing with the clearinghouses. Ok, I’ll do the follow-up together so it’s all one question. I get the impression that there are clearinghouses, and it’s not just the impression, I think I have real data about this, there are clearinghouses that can supplement the providers data to the point of making it compliant, and there are other clearinghouses that cannot supplement the providers data. And I’ve seen when the clearinghouse supplements the provider data they get compliance levels of 98 percent in some cases, even when the provider submitting a current NSF or UB92. Have you looked at those results and where are we in the compliance? Not in the testing, but in the compliance.
MR. ARGES: I guess I’ll comment. From what I’ve seen or what I’ve heard is that some providers have submitted claims for testing and initially obviously many of the items failed. And part of it is the new items that are required as part of the transaction standard that have not been a routine part of the adjudication system, and that has caused an awareness problem. For instance, the insured’s birthday on a UB92 is a new item, something that has not been routinely collected, many thought that health plans should probably already have that on their system, but yet it is a new item. So the question then becomes can the clearinghouse fill that in. And the answer is probably not unless they are privy to that type of information. Or whether a health plan should relax their edits, even though it is a required item, but I think what is needed here is some guidance from the Department to tell the health plan that it is ok to relax this edit because they don’t need it for adjudication of the claim. So I think that’s one element where it would go a long way to basically streamline the process.
MR. TENNANT: I think from my perspective and a lot of it is anecdotal one of the problems here is that they tend to test with one health plan, so they’re working with their Blues or their FI, and things have gone fairly smoothly from what I’ve heard. Where it’s gone into trouble is if you’ve got a multi-specialty clinic where they have a central billing office, it’s difficult to get patient encounter data, it’s more of an operational problem where they’ve got to train staff in their facilities to collect new data. But one of the problems that we’ve encountered through our survey questions is the vast majority of our members have not yet received any information from health plans regarding any testing schedules, so they would like to begin testing but they haven’t yet received anything from the health plans, and we’re encouraging them to be proactive on this but it’s difficult to get them to move in that direction.
DR. COHN: Let me ask one question, I apologize, obviously we’re being sort of stretched for time here a little bit. A number of you have sort of supported a lot of the WEDI recommendations, and I think George you’ve only got a slightly different take on it, I think effectively you’re describing really implementation issues around some of these recommendations. The part that I’m curious from all of you has to do with timing, and there’s words like temporary and short term and all of this, and I guess bringing it down to something that’s actually a recommendation, there’s two pieces to all of this. One is allowing, asking health plans to accept non-standard transactions, which I presume would be sort of, a requirement of that might be that they have to be in active testing with that entity, there needs to be some certification of that, but how long of a period would that transition be, was it six months, four months, is it 45 days until January 1st. And then the other question which is a little more interesting is that issue of yes you’ve got the right transaction but you don’t have all of the required pieces, which is something that once again seems to me to be something that gets worked out with a more prolonged testing strategy. And how long of a period of time for that? Could you three just briefly comment?
MR. CUNNINGHAM: That was part of the reason that I tried to link it to the question of enforcement because I think you’re asking a question that in some ways is unfair. I as a provider can’t tell you how long it’s going to be before my vendor is ready to help me with the testing, and I can’t tell you once that’s done when my clearinghouse will be ready or the payer at the other end. And therefore to ask me how long we should allow this transition period to go on, I don’t have a very good answer to that question, the answer is as long as it’s necessary in order for the system to work. You’re asking one fragmented element of the total system to respond to how long it’s going to take the total system, and you’re probably in a better position to judge that than we are. I think it’s going to take some flexibility and I think we’re all going to need to be pushing everybody but the judgment should lie with HHS as you go along and can see that we are making progress and that people are doing what they are capable of doing to comply. And frankly, I’m not sure that it’s such a crucial thing we fix a date. I was just commenting earlier in a conversation how many providers have actually complied with privacy, all of them? I don’t think so. Does it matter if it stretches out as long as we’re keeping on progressing? I don’t think this needs, I agree that I don’t see why it should take a year, but I would be hard pressed to say how long it should take and I think the name of the game is to manage the whole system and make it move forward, and if it does, if at the end of the year we’ve already arrived, hallelujah, I would say we’ve made a huge, huge stride.
MR. ARGES: Well I guess I’d like to comment on the statement you said. AHA does not support using non-standard transactions. We support using the 4010-A as a means of submission. And it may be appropriate, let’s say, for a health plan upon receipt of that, and they realize that there are deficiencies in that claim, for them to basically adjudicate it as though they were to adjudicate it under the pre-HIPAA world, in which case they can determine as a means of avoiding the type of arbitrary interim payment to basically calculate what the payment would have been under normal circumstances and then make payment as part of that. But the important thing is that providers start using the 4010 and then have the health plan identify any deficiencies that they find with the specifics so that they can correct it down the road. Otherwise, I think if you allow the reliance on the continuation of the non-standard formats no one will continue to move in that direction. We did talk about a six month period where at least interim payments should be a real means of support.
MR. TENNANT: I think Carl’s absolutely right, I mean there’s not an arbitrary line in the sand, whatever line in the sand was there is not something that’s going to be harmful to the industry if it slides. For example, the federal government itself missed its own compliance deadline of 2002, so I think our position is that similar to Carl, we need to have the system flow smoothly. If non-standard transactions continue to flow through the system over a period of time it’s not the end of the world. The end of the world is when cash flow disruptions impact patient care, and so that’s the most important thing here which we’re kind of forgetting as we don’t want any interruption into patient care.
MR. HOUSTON: Does it make sense, because obviously I think the most important transactions at least from my perspective are 835 and 837’s, that maybe we focus or try to make a recommendation that focuses on trying to get compliance with both of those transactions first and then maybe looking at some of the other ones in some type of tiered order afterwards, like eligibility next, maybe something else, enrollment/disenrollment after that, because I think, my concern is is looking at the earlier Gartner presentation it appears that maybe there’s a lot of activity going on in some of the other transactions. What I think what I’m hearing is that the two most important are 835’s and 837’s because of the payment component of it. Is there any thoughts on that?
MR. ARGES: No, I would agree that the 835 and the 837 should be the first focus in terms of contingency planning, I think those are the key elements that impact the viability of the provider organization and those have to work, there’s no question about that.
MR. HOUSTON: Maybe even further than that though, should there be some thought as to the other transactions to be some way be tabled or delayed or at least from a testing perspective that there’s a priority for everybody to be doing 835 and 837 transactions first, just a thought.
MR. ARGES: I think there are some other problems with the other transactions, more than just a compliance perspective. I think there’s more guidance that needs to be given around the information that is provided within the other transactions. I’ll give you an example, the eligibility transaction. When the provider does an eligibility inquiry and all they get back is yes they’re eligible, from a provider perspective that’s inadequate. We need to know the type of deductibles, co-pays, those type of things, that really make that transaction worthwhile.
MR. CUNNINGHAM: I guess I’d just add from the small practice standpoint claims is the only thing we’re doing, so basically if you say well you’ve got to be compliant if you get into eligibility checking or pre-certs or referral authorizations, claims status, that’s fine because we’ve never done it in the past so that if we’re going to start doing it electronically we might as well do it in the standardized format. But we’re probably doing it all by paper now or by telephone, so yes, the only thing that we are doing on any large scale that is going to really impact us is the claims and it’s the payments that we’ve got to have in order to survive.
MR. TENNANT: Just to echo that, I agree that those two are critical, however, we don’t want to penalize those providers that have adopted the other standards, eligibility, claims status, all those are going to be saving money and we want to encourage that as quickly as possible, but certainly the focus has to be on the claim.
DR. COHN: Thank you very much, let’s move to the industry reactor panel and thank you for your testimony.
Thank you for joining us. Once again we apologize, we’re trying to put a lot of testimony into a relatively short period, so if we could have you each hold your comments to somewhere around five to seven minutes so that we have a chance to talk about the issues a little bit we would appreciate it.
Agenda Item: Industry Reactor Panel - Mr. Bechtel
MR. BECHTEL: My name is Don Bechtel and I work for Health Care Data Exchange which is a Siemans Medical Solutions Company. But I’m also the current chair of AFEHCT, or the Association for Electronic Health Care Transactions and I’m here today to testify on behalf of that organization, AFEHCT. My remarks today are going to focus on our membership comments that we have collected to make this testimony, and I would like to thank you, the vendor community that I represent would like to thank you for this opportunity to have us here and present to you today.
This morning I’d like to share with you what we see as some of the obstacles towards achieving compliance with the transactions and code sets, and some of the solutions to those problems that have been identified. I’m not going to read this whole paper, but I am going to read parts of it.
I believe that it is accurate to say that all the AFEHCT members are currently in the testing phase. They’ve completed their development work and I think we’re all in the phase of testing. However, I think some of our vendors, mostly in the practice management solutions area, and when I say our vendors, in our community, not the AFEHCT vendors per se, may be struggling with some of their remediation. And that work probably focuses on several different things.
I think we’ve heard a lot of those comments already and I’m not going to go into that in great detail, but what I hadn’t heard, perhaps, is that some of the causes for some of these vendors being late is the fact that addenda came out late and some of the final steps of their development work depended on that. And I think in terms of some vendors were also saying that the companion guides were a necessary component to some of the work that they were incorporating in the coding as well. And the companion guides coming from the health plans have also been late arriving, and I believe the reason that we’ve seen this delay is also due to in part, if not largely, to the addenda being late, or at least late in the cycle for what we’re trying to accomplish.
Some of the problems with achieving compliance. The AFEHCT membership believes that the health care industry and the HIPAA community at large are not making nearly enough progress and I think that statement is fairly well substantiated by some of the information we saw from Wes Rishel today. I think the progress has not been at all what we would hope. I think what we are experiencing are a number of problems getting through this compliance or transition phase, and those problems seem to fall into three areas that we’ve been able to identify, and again you’ve heard a lot of this already today. The first area is an area of testing. The second area would be in data content. And the third area would be in overall project management.
Looking at the testing problems the necessary trading partners that we need to be testing with just are not ready, or they’re not ready to test with us, whichever the case may be the point is we’re still not testing. And I think that was also shown in a number of the statistics that were shared with us earlier today.
Some of the other problems that we seem to be facing when we do start to test is that the significance of this effort is quite complex. We’re not only testing the transactions and the content and that our systems are performing the way they need to be performing with all new remediations that we’ve made, we’re also seeing changing technology, both in the way we deliver the transactions, the way we receive the transactions, and also in the way we use translators, which many of us have not used in the past, and now with the implementation of X-12 we are using translators. These are adding more complexity to the system, they’re adding more points of failure, and so it takes us longer to get through this. So I think the testing phase is dealing with more than just implementation of these transactions, there’s a lot of components to this that are having other effects.
As mentioned, the companion guides really have delayed the testing because companion guides, trading partner agreements tell us how we do the testing, they tell us how we have the connections and we’d do security and all the things that we need to do to be able to start this exchange of data flowing. Without that information we haven’t been able to begin.
Re-enrollment is another area where we’re experiencing some difficulty. Re-enrollment is having to re-identify who are our providers are to the trading partners, particularly the plans, so that they can re-enroll them in their new systems and we can continue to do the transactions between the clearinghouses and them or the providers and them directly. This re-enrollment processing is taking substantial amounts of time, it’s administrative time, it’s not testing time, and it’s time that’s delaying the testing effort.
In terms of data content, again, Carl Cunningham has done a very thorough job of explaining this issue I think. From the vendors perspective, on the practice management side we are experiencing or seeing the industry experience problems with data content not being there. I’m sure there are many reasons for that, the ones that we believe are most realistic is these providers in the past have always relied on clearinghouses, those vendors have always relied on clearinghouses to do these transactions, and it was a natural assumption to continue to believe clearinghouses would do the job, not realizing that there were content issues here and those content issues were being addressed just now, or those vendors are just beginning to understand that impact.
Were also having other problems in terms of implementing these transactions, this has already been mentioned by Steve Lazarus from WEDI. We have other issues that are facing us besides the claims, we have the secondary claims, we have COB issues. The bigger problem here is we have a lot of questions about how we do this processing, questions that aren’t yet being answered, so it makes it very difficult for us to move forward with some of those. So we definitely need a process by which we can get answers to these questions, get those answered quickly, so that we can begin to do the work that we need to do to fix and make these transactions flow.
We also see that we’re experiencing people issues, people issues in the sense that we’re learning new systems. The people that support these systems, these are new systems, they have to have new processes, new methodologies by which to do that support. This is a learning process. Not everyone in the organizations know these new systems yet, and a lot of the people that are supporting the older systems now are in transition and so we see resource issues becoming a problem. Certainly some form of capacity is becoming an issue.
So elements of a solution, what we believe will help us, is we need to adopt a plan, I head someone ask just before this panel came on, would a plan be helpful. And I think a plan is absolutely essential, I think we’ve been lacking that for some time and we’ve all been working on our own internal plans but coordinated among the trading partners that consistent planning doesn’t exist. We need something with timetables and milestones, something that we can monitor and manage the process. We don’t really understand how big this issue is and we’ve heard a number of presenters who showed you statistics today that illustrate that we really are only seeing a small sample when we do these statistics, and I think we really don’t have a good grip on how big this problem is and where are the problems are, and we’re finding them as we test. So we’re doing kind of alpha testing as we go it seems to me.
I’d also like to point out that I think our membership, our vendors and clearinghouses, are in a great position to assist in the testing. We think we’ve remediated our systems and we’re ready to do some of this work and we can do some of the early testing to shake these problems out. We are prepared to do that. And as a clearinghouse I think we’re also in a position to help accelerate the implementation from the small provider perspective. But there are a number of issues that we need to address to allow us to do that, and we’ve heard some of those comments from the WEDI position, from the perspective of operational compliance. If we have a way of being able to support operationally compliant transactions as opposed to having fully compliant transactions we think we can move the industry along more quickly. And we also believe that that’s not for everybody, there’s a lot of work involved with being operationally compliant, it means retooling our systems, it means additional remediation, and that’s not necessarily always an option. So we also believe that we have to support the other notion that WEDI presented, which is to allow the existing transactions that are being used to continue to be used until we can complete the transaction, I think we need to consider that this is a reasonable way to go forward if everyone is showing progress. And that’s what we would like to recommend.
In terms of some of the data content issues, again operational compliance will help us achieve that, and I also believe that some sequencing, some planning with these other transactions is needed. We’ve been very focused and rightfully so on claims and remittances, but these other transactions still need to be done, too, and that testing has been very limited.
Thank you.
Agenda Item: Industry Reactor Panel - Mr. Daley
MR. DALEY: Good morning, I will try to paraphrase this statement in the interest of time. I’m Jim Daley, the HIPAA program director for Blue Cross/Blue Shield of South Carolina. We provide health benefits, dental, vision, pharmacy benefits, life insurance, workers’ comp. We’re the largest Medicare and TRICARE processor in the nation, and we do some Medicaid services for the for the state of South Carolina. We have a subsidiary that offers software and clearinghouse services to providers, so we have a wide range of services. Today I’m speaking on behalf of the Blue Cross/Blue Shield Association. BCBSA represents 42 independent Blue Cross/Blue Shield plans, insuring about 85 million people, or one in three Americans. And I do thank you for the opportunity to testify this morning.
As far as the state of industry readiness, the Blue plans will be compliant by October of this year, but we feel there will be a certain percentage of our trading partners that won’t be ready, and that’s our concern. We’ve done some informal surveys, not very scientific, and we think perhaps 20 to 30 percent of our institutional providers may have some issues, and potentially 30 to 40 percent of the professional side, again these are very unscientific surveys, but it indicates there is a good number out there that may have some issues.
There’s a variety of reasons for that, you’ve heard those reasons before, and I won’t go into them, they’re in our testimony. However, there’s also another situation of any time you get into an effort this large it just takes longer than you thought it would.
As far as our outreach, we have done significant outreach programs from the Blues, this week we’re going to release a HIPAA Transactions and Code Sets toolkit. That will give providers a better understanding of the regulations and all the steps they’ll need. I know CMS has done outreach, many people have done the outreach programs in the past. We’ve done individual outreach programs within our state, as early as over a year ago. However, the message still hasn’t gotten out there as to just how much needs to be done and what it will take to do that. And there are the misperceptions that my vendor will do it, I’ve bought some software, I use a clearinghouse, there’s nothing for me to do I’ll just let them come in and make me compliant. And that’s been part of the problem as well. Now the reality is hitting and people are having a better understanding of what it’s really going to take.
One of the other issues we’ve heard about is clearinghouses, they can of course be part of your solution, but we’ve heard a couple stories that some clearinghouses are reaching capacity and may not accept new customers, so that may be another issue we have to face here.
Consequences of non-compliance, they’re significant. The law requires you to accept and use the compliant transactions, so in effect we’d be violating the law if we went and did something else. However, if we don’t have some sort of contingency action there could be other consequences, we’ve heard cash flow issues, the dropping to paper which would add additional expense and increase the administrative burden to the industry. So something needs to be done. One of our estimates plan did a study and found they feel it will take about $2 dollars more per claim to process on paper, so that’s not a road that we would prefer to have happen.
We don’t support another extension. We worked hard, we took advantage of the extra year to become compliant. However we do recognize that something needs to be done to bridge the period between us being ready and all of our trading partners being ready, or in fact, even if we are both ready to get us actually transacting between each other.
WEDI has sent a letter into Secretary Thompson discussing a couple of options for contingency. I’ll discuss each of those options. The first one of permitting the compliant entities to use a “standard format transaction that may be missing some data elements”, that’s not a great option from our perspective. Again, we would not have a problem if someone chose to use that option, but it’s an option that does not look good to the Blue plans. We spent a lot of time and effort reading the implementation guides, doing the interpretation, purchasing the software, to actually do a strict adherence to what the standards say is required. If someone said you need to back off from that standard, that would be additional development effort to actually go backwards in our processing, possibly on a temporary basis, where at some point down the road they say ok, now take it all back out and go back to the way you were. That’s just an extra expense that does not make sense. It would not be viable on a trading partner by trading partner basis. Hospital A says I can give you all but three elements, provider B says all but four elements, it just is not workable.
The other question we have is also many of us have web DDE applications. We’ve tooled them to be compliant with the actual strict IG requirements. Would you then have a situation where your web does things one way, your EDI does it a different way? That could raise additional issues, so there’s a whole bunch of complications that would come from this “operational compliance.” But again, if someone feels that’s viable for their payer entity that wouldn’t be an issue.
As far as the Blues permitting the covered entities to establish a brief transition period to continue accepting their current transactions, we’re using those transactions today, maybe there’s some flaws with them, however the system is getting the claims in and payments back out, so the cash flow is occurring. That’s the best contingency that we have. Now we’re not in favor of just saying lets continue doing that, however, if an entity is trying to become compliant, they’ve taken the right steps and they just haven’t gotten there by October, then we feel this is the most viable alternative. Ok, continue what you’re doing as we continue to work with you on a test basis to tune up those transactions so that we can converse with each other and conduct the HIPAA transactions. And as soon as that’s ready say ok, now we’ll shut off the old and now you’re live on the HIPAA formats. And that we could do on a trading partner by trading partner basis. We feel that’s probably the most workable alternative.
We have done some studies and we believe that there is some authority, some past situations where enforcement has been lenient in certain situations, so we believe there may be a way to make that contingency be viable.
We do encourage HHS to announce the contingency action soon so that people can prepare and know what’s down the road. And again, I do want to encourage, we aren’t saying announce to everybody they’ve got more time, but just say if you are having some difficulties, your vendors not ready, your clearinghouse isn’t ready, or you think you’re ready but you haven’t been able to test with a payer, announce what will be the acceptable courses of action so people know you can plan ahead as to what they’ll need to do.
And of course, continued outreach, call to action, and continue to enforce the fact of you need to be ready for HIPAA and keep working hard to reach that goal.
That in a nutshell is what is in my written statement, thank you for the opportunity to testify, and I’ll turn the floor over to Tom.
DR. COHN: Jim, thank you very much. Tom Wilder.
Agenda Item: Industry Reactor Panel - Mr. Wilder
MR. WILDER: Thank you very much, my name is Tom Wilder, I’m with the American Association of Health Plans. I do also want to thank you for the opportunity today to discuss where our health plan members are in terms of implementing the transactions and code sets rule. I’ll make a couple of comments and then I’d be glad to answer questions.
What we’ve been hearing from our members is of course what all of the groups up here have indicated, which is that their members are working very diligently and we’re expending significant resources to comply with the rule. There is some concern among our health plan members about whether or not all of the covered entities will be ready on October 16th to implement the requirements of HIPAA. In a sense the surveys that you’ve seen and the charts and the graphs really are irrelevant. Not that they don’t give you a sense of what’s going on currently, but the true test is what’s going to happen on October 16th. Will everybody be prepared to send and receive HIPAA compliant transactions?
And in a sense, who’s fault it is really is irrelevant. As all the groups here have expressed to you, we’re all very dependent upon our trading partners. To steal a phrase from Dr. Franklin we either all hang together or we’ll hang separately. A health plan could be ready, they could have done all the testing, have all the proper software in place, but if a portion of their trading partners aren’t ready then they’ve got problems. Same can be said for hospitals or for a providers office. You can be ready but if your business partners aren’t where they need to be there’s going to be some disruptions. So what we need to do is figure out a way that we can all work together to get to where we need to be in the most appropriate fashion.
What I’ve been hearing from our members when we’ve been talking to them is that they’re going to do whatever they think is necessary to pay claims, that’s what their business is and they want to make sure that they can get all those claims processed in a timely fashion. What they are absolutely scared to death of is people going back to paper formats, going back to paper claims quite frankly. We all know that electronic transactions are a lot quicker to process, they’re less expensive, and more accurate. And both providers and health plans have made tremendous progress in terms of transition to electronic commerce, and going back to paper would be a significant step backwards. And so whatever suggestion that’s come up with here and whatever HHS will ultimately do should not force people to go back to paper claims.
We do not support a delay in the rule, we think that whatever solution may be done by HHS, whatever guidance or fix-it they would suggest can be done without delaying the rule. There are significant advantages to the HIPAA standards, everyone has worked very hard to reach that goal and we don’t think that goal should be relaxed. We do think that what is needed is some flexibility to allow those folks that aren’t going to be fully ready to implement the rule on October 16th to allow them to continue to process transactions in an orderly fashion.
I very briefly want to comment on the WEDI letter and also on the suggestion that was made to you by the hospitals in terms of a contingency plan. Quite frankly our members are still trying, as an association we’re still trying to think through the WEDI suggestions, but I do commend them for looking at this issue and really bringing everyone’s attention. Again, I can just share with you what I’ve heard from our members, and it’s very similar to what Jim told you in terms of the Blues plans. A number of our members quite frankly are going to probably, what I would in my kind of non-technical fashion say they’re going to dual track claims, because that’s what they think they need to do in order to get them paid. They will continue to accept so-called non-compliant formats. Some will in a sense relax their front end edits, which is this whole it may fit the standard but not the content, although they don’t want to be required to do that because of the way their front end editing systems are set up. It may be very difficult for them to go back and now relax those edits.
Whatever solution that people come up with, the other message we’ve heard from our members loud and clear is don’t paint us into a corner. There is no one size fits all approach, again, give people the flexibility to be able to do what they need to do after October 16th to process transactions and to do their business, and don’t tell them that this is the new approach that we’ve adopted to get things done.
We have briefly discussed with our members the approach that’s been suggested to you by the AHA, even if CMS had the authority to order plans to set up a payment system, which I don’t believe they do, is from our standpoint not a good idea. This is probably too flip of a response but to me it’s kind of like you go into your grocery store and you pick up a carton of milk and a loaf of bread and you go to the check-out counter and the clerk says well, you spent a hundred dollars last week on groceries so I guess that’s what we’re going to charge you now.
And with that I’d be glad to answer any questions that you may have.
DR. COHN: Kepa why don’t you lead off?
DR. ZUBELDIA: The proposal from WEDI, both proposals from WEDI to either have flexibility of relaxed edits or to continue accepting all legacy formats, apply to compliant covered entities that have the most, they are compliant but perhaps part of their trading partners are not and with that part that is not compliant they will deal different. What’s your recommendation, if any, for those covered entities that are not compliant? Specifically, providers that have not upgraded their software for instance, or have not done what it takes to become compliant and still need to get paid.
MR. DALEY: That’s a difficult situation. Again, in our situation, we would have one party compliant which would be us, and we would certainly want to continue the cash flow. We would follow direction from the government, if they say if a person is not testing with you, if a person hasn’t reached some state, whatever they give us for direction then we would comply with that directive. We certainly don’t endorse people saying I’m not ready, you’re not ready, let’s just keep doing the same old thing and no one will know about it, I do not support that.
DR. ZUBELDIA: What’s your recommendation to do with those?
MR. DALEY: I think at some point we should say turn them off. Again, I will leave that up to the federal government to provide direction in that regard. If they say you should be turned off as of October of this year if you’re not even testing, we will abide by that directive. If they say give them a few more months to become testing, we’ll follow that directive. But it’s not for me to decide what the national direction should be in that regard.
MR. BECHTEL: I guess I wanted to respond to this in a different perspective. You phrased your question that operational compliance is for those entities who are compliant, and I want to point out that I don’t think that’s always true. Or maybe said another way, I might be a compliant organization, I have my systems ready to do what I need to do, but I was unable to complete the testing with the new implementation with by trading partner, and I cannot exchange those new transactions with them yet. And the only way I have of exchanging data with them is with the old formats, because that’s the only vehicle that’s still working. So I could be compliant but not able to exchange compliant transactions, and I think that situation is going to exist for a number of entities. And that’s why I offer that we need both solutions, for covered entities that are ready and for those that are not.
MR. WILDER: Again, the issue in a sense really isn’t who’s compliant and who’s not, the issue is how do you make sure that the trains run on time and the claims get paid. To echo what Jim said, I mean from a plans perspective they’re going to first try to work with the provider to make sure that the transactions will get accomplished after awhile if a provider is not compliant. Yes, they’re probably going to turn them off but again, the thing that weighs most heavily in their mind is is that going to force a provider that you do a lot of business with to go back to paper claims, because they don’t have to use the transactions.
MS. TRUDEL: I’d like to follow-up on what Jim was saying earlier about the option of the relaxed edits not working as well for plans because of having to un-tool and retool to tighten edits that are already in place. And I guess my concern comes from a worry that we might be talking about offering too many contingencies. And I guess my question is under what circumstances, and I know I’m sure the WEDI Board thought about this, under what circumstances would the option of relaxed edits accomplish something that maintaining the old formats would not? And maybe we need to have someone from WEDI come up and talk about that.
MR. DALEY: Let me take a quick shot at that one, I am from WEDI as well. One of the situations where I think it could work is if we have an industry consensus of saying there are several data elements that are in the standard that were adopted some time ago, and now that we’re in the throes of implementation we realize that we don’t have the data, it’s not all that critical, and in fact the standard should be amended to remove those data elements. And that situation, if we said our intent is we are going to pull them out of the standard, in the interim take steps to remove them from your edits and relax on those particular items, that would be a viable approach with the concept that they would be removed from the standard at some point. If it was only for a temporary basis it would not work, and it would also have to be across the board, not on a trading partner basis.
DR. FITZMAURICE: In listening to the vendors, the providers, the clearinghouses, and the health plans it seems to me that the providers are saying gee, we’re just learning that the data content would change, we relied on our vendors to make sure we’re getting our cash flow. But if we can’t get our cash flow would you please make sure we get our periodic interim payments based on our past grocery store purchases and the number of packages that we purchase. The vendors say well, we needed information from the health plans, we needed the companion guides which are slow in coming and the clearinghouses to specify our new software and update our old software. And we needed the data content from the providers. Clearinghouses needed the same thing, the data content, the health plan specifications and companion guides. The health plans and the payers are saying well we needed the addenda before February 2003, adjudication is complex, testing is complex, but we’re going to be ready come October the 16th, 2003. I hear Jim Wilder say, excuse me, Jim Daley, was that we’re going to be compliant and to be non-compliant or to deal with non-compliant people gives us a different kind of economic model. It’s going to be more expensive for us to deal with these non-compliant people. And so I’m going to create a mythical scenario that Jim did not say, but it’s mythical in my mind, an economic model whereby you say you’re non-compliant, there’s going to be a higher charge for you. And of course I think the higher, the maximum we could charge is $100 dollars per transaction and the aggregate of these charges we will make wouldn’t be more than $25,000 dollars a year. And here’s an incentive for you to become compliant. So we’re now kind of debating on whether we’re talking about penalties under HIPAA or a price per transaction that goes up to the boundaries of what a HIPAA penalty could be. Where in my mind I’ve been thinking all the time about what can the government do to set strict time deadlines and to encourage compliance so we can get to these efficiencies and uniformity of health care claims, here’s another model that’s just been sprung upon us, an economic model that applies more incentives than just government regulation. Something to think about. I propose it as a mythical scenario but there may be something behind it. I’ll open it for any comments but if you don’t have any comments that’s alright, too.
DR. COHN: Let me just toss out something to our reactor panel, and I’m actually, once again I’m sort of struggling to see if there’s sort of, if we can begin to come to some sort of a common view. I guess I’m hearing certain things, one is there’s a set of WEDI recommendations, I’m hearing that the industry is probably not going to be completely ready by mid-October with all of the trading partners all equally competent at all of these transactions. The question is is what happens then, and certainly one of the questions I have is geez, should we set as a requirement for any sort of transition or otherwise that everyone at least be in testing by October 15th to move forward. And then the question is, and this is maybe based on Jim Daley’s sort of comments, that WEDI had talked about sort of two proposals, and I remember your comment had been geez, it would be actually sort of difficult for you to handle a sort of a subset of a standard transaction, but you didn’t have any objection if somebody else wanted to do that, whereas your view is that it made a lot sense to maybe allow people while they were testing to at least be able to continue to do business with the previous transaction. So the first piece could be on the basis of trading partner agreements during the training, and the second piece would be something that was just allowed during the transition. Is that a model that sort of makes sense? I mean I don’t know what period of time we’re talking about for that transition, but does that make sense to people? Is testing the sort of basic expectation knowing that we had expected that on April 14th or April 15th, but now is it like really required and what about the other pieces?
MR. DALEY: I think it’s a viable model. In terms of some of the things you’ve discussed it’s what we do all the time, we have an existing system or process in place as we’re building and testing the new one, and at some point we say the new one is working, we turn off the old one. Sometimes we do it across the board, sometimes we do it for selected people, departments, systems, whatever, but that’s a process used for system development since I got into the business close to 30 years ago, actually now it’s over 30 years. But that would be viable. And again it solves the cash flow problems if you continue with the current system, that’s your built in cash flow.
MR. BECHTEL: I would suggest that’s exactly our position as well, our position I’m speaking now as Siemans for a moment. The operational compliance has retooling issues as I mentioned that I think just elongate the process, it just puts more work on the table, and I believe the way we have done business as Jim just pointed out is exactly what he described. It’s a more practical way to go forward and I think if we can show that we’re making progress in that transition that that should be adequate.
MR. WILDER: I would agree with Jim’s comments that again, building in some kind of transition to allow everybody to get where they need to be is what we’re asking for.
DR. COHN: Kepa and then Jeff and then let’s sort of see if we can put it together.
DR. ZUBELDIA: I’ll venture to say that that concept was what ASCA I think had envisioned, but it was a complete failure because there was no way to actually measure it, and measure that there is testing. So one of the recommendations that we’ve heard today is that there be a measurement of the reports going back to providers saying these things that you are testing with are wrong, so could we couple Simon’s proposal with a measurement of improvement in order to maintain the continuity of the old legacy formats, you have to be testing at least improving your testing for no more than three, four months, and you have to become compliant and have a measurement of how the testing has to improve. For instance a health plan could set goals that no more than 80 percent of the providers be on the legacy format on day one, October 16, and no more than 60 percent on the next month, and no more than 50 percent in the next month and so on to make sure that it actually happens because I’m afraid that some entities may start testing and continue sending the real stuff in the legacy formats forever.
DR. COHN: So whatever recommendation would have to get rid of that forever part, right. Jeff, do you have a comment or a question?
MR. BLAIR: If I heard things correctly, there’s a concern that certain covered entities won’t be ready but I’m also hearing that for the most part the health plans, Blue Cross/Blue Shield of America expects to be ready. The concern doesn’t seem to be as much that the payers won’t be ready, and the AHA testified, George Arges, that he would not want to see a delay. It sounds as if the big concern is the small ambulatory providers and maybe the rural providers. And if this is correct can we target those folks for the additional testing and not the payers and the acute care institutions. Can it be separated, will that be helpful? Because I was also hearing a lot of concern that if we wind up extending the enforcement for everyone then people will wind up relaxing and it will be just moved back to the next deadline and we’ll still wind up having this convergence. In any event, should we focus on the ambulatory and the rural health providers, is that workable?
MR. BECHTEL: I think you’re right about where the majority of these issues exist but I don’t think it’s the only place they exist, and I think, in my mind the testing is still the difficulty. We’re having a hard time getting through the process because there are lots of things impeding it. And I think even though the health plans and the providers, the large institutional providers are ready, they’re not completed in their implementation because they don’t have the time they need in my mind to get through the process. So I believe we need to leave this open to all entities, not just the small providers. The small providers have an issue with data content, but as I pointed out in my testimony there’s two major issues here, the time to get the testing and the word done for that. And the second is we have small practice management vendors who are coming up short on the content. So I think there are two problems to fix.
DR. COHN: Karen and then lets try to wrap up and sort of make sure we’re all on the same page.
MS. TRUDEL: I’d just like to remind everybody of one issue that occurred as we were implementing the ASCA legislation and that was that that particular piece of legislation, instead of giving everybody a year, said that you had to come in and request it and you had to tell us what your plan was. And one of the things that we very consistently heard from both providers and health plans was we have enough on our plate right now, we really don’t want to have to do this as well, request this waiver. And so I think we need to remember that every time we put a burden on the health plans to check to see whether the person’s in testing, check to see whether their status has improved, check to see if they’re small or they’re rural, we’re putting an extra administrative burden on the health plans that will necessarily take away from their ability to get people in and get them testing and processed. And I see Jim nodding, but maybe you want to say yes so the people on the internet can hear you.
MR. DALEY: I totally agree with you, Karen.
DR. COHN: Well, let me try to put this together a little bit and actually I’m not sure that we need a specific recommendation regarding rural and small providers, though it may be a sentence in some sort of a letter we write, but what I’m hearing a, is that sort of the fundamental requirement, a, we don’t think that everybody is going to be completely up and running October 15th across the industry, we obviously want to protect the industry. That’s number one, so the question is is what sort of transition does one provide, and I think that what we had talked about was that being in testing was sort of a fundamental bar that you needed to be in before there was any sort of allowance for anything that was non-standard after October 15th. And I think after October 15th what we’re assuming that if somebody is in testing that at the very least they should be able to send sort of the previous old transactions and their old formats until such time as they’ve gone through testing and have gotten themselves certified and that everything is sort of copacetic and working. Then on the basis of individual trading partner relationships there can also be decisions made about during that period of sending sort of things in the standard format but not the complete set of data elements, but that’s really a trading partner relationship. But all this as I said is only allowed if people are in testing.
We are also per Kepa suggesting that the testing not go on forever. And I’m not even necessarily going to try to come up with a number of months or whatever, I think we’ve heard less than a year or probably it might be four months, six months, whatever, but we can sort of discuss that as the letter gets developed. Now am I capturing the sense of the Subcommittee in terms of a letter to be written? Kepa, does that satisfy your basic needs for a draft letter?
DR. ZUBELDIA: Yes, but I think there’s a point that’s still lingering, and that’s the distinction between compliant entities being allowed to do this and everybody being allowed to do this, and the way the recommendation is specific to compliant entities only being allowed to do this and I get the sense that even if they’re not compliant, as long as they’re testing and they’re trying to move along they should be allowed to do it.
DR. COHN: So you’re agreeing with me.
DR. ZUBELDIA: Yes, but I want to make sure that we note that distinction because WEDI specifically only addresses compliant entities, and I think that there will be a good number of providers that are not compliant, they’re trying to do testing, they’re trying to become compliant, but they haven’t been able to prove it to anybody yet. Not even a single trading partner.
DR. COHN: Ok, well I think this is additional wordsmithing so --
MR. BLAIR: There’s one other refinement that you might consider as we try to pull together a consensus, and that is whether or not we apply this specifically to the health claim transactions or to all transactions.
DR. COHN: Well, I guess my vote, I vote for simplicity and I would apply this to all the transactions. Does anyone have an issue with that, or concern? I mean considering that all the transactions are required on October 15th --
MR. BLAIR: Maybe I phrased it wrong, maybe what I’m saying is that we tend to be focused on the health claims right now, if we start looking at the other transactions they may need even more time.
DR. ZUBELDIA: I think the recommendation from WEDI and what I’ve heard today is kind of in the opposite direction. I heard today that the other transactions in general have not been implemented and if you’re going to implement it just implement the standard, there is not this legacy, of legacy transactions that could disrupt the cash flow, so I’m not sure that the other transactions need any kind of legacy allowance like the claims do.
DR. COHN: I think the final comment I would make in the letter is that I don’t think we heard any testimony today from anyone calling for an extension of the compliance date. So I want to thank you, we’ve all been through this, but I think it just sort of speaks of how far we’ve come from the beginning, from the rule being in an NPRM to final rule, to ASCA, and I think it at least speaks of a maturity in the industry. Jim do you have a final comment before we adjourn?
MR. DALEY: Just a last comment is again, what we were proposing were option contingencies for compliant entities. If there was a given compliant entity for whatever reason could not avail themselves of those options then they shouldn’t be backed into a corner to try and accommodate someone who didn’t come into compliance on time. So we want these as available options versus mandated options.
DR. COHN: Well I guess I have to ask the Subcommittee, what I was sort of reformulating your comments to be that there at least needed to be one option, and that the other option was between trading partners. Just once again, an issue of simplicity. I don’t think we want to have any payers physically prevent providers from being paid on the basis of unwillingness to accept anything, unless it’s a fully compliant transaction, so I guess I have to look to the other members, is that a, I mean once again this is a draft letter we’re putting together, we’ll all have a chance to look at it, is that the sense of the committee, Kepa?
DR. ZUBELDIA: I think the clarification of what is a compliant transaction should probably be made in the letter, and I think we’ve heard today some of the comments on payers rejecting an entire batch of claims because one claim is bad. I think the industry is needing some guidance in that area, that if a batch of claim has a 1,000 claims, it’s each of the claims that is standard rather than the entire batch that is one standard. And I think that clarification will benefit tremendously.
DR. COHN: Ok, Kepa, so what you’re adding to this is a sentence or two asking for HHS and CMS to clarify the meaning of a compliant transaction. Ok. Mike? I would like to go out to lunch but please go for it.
DR. FITZMAURICE: You’re looking with trepidation at me. I’m only going to suggest that we might want to run the draft of a proposed letter by the Office of General Counsel so that we can avail ourselves of the advice they might give us so that we don’t recommend things to the Secretary that he do that might be illegal.
DR. COHN: Thank you, Michael.
DR. ZUBELDIA: There is something that I haven’t heard today specifically, but I’ve heard in the last few days and there was a WEDI meeting yesterday, and that’s concerning perfection versus turn arounds for certain errors in the transactions. And I don’t know if it’s appropriate for us to recommend a clarification on that or what should be done. But in that same batch of 1,000 claims if there is one bad claim that is still acceptable as to the payer, and payable by the payer, and meets the requirements of the payer, and they’re all HIPAA compliant transactions except that there is this one that perhaps doesn’t have something, we’ve heard about that today, and I’m wondering if that sort of clarification would be beneficial in the letter.
DR. COHN: Kepa, without trying to argue with you about it I actually think that you may be the person to help us write a paragraph having to do with questions for clarification from CMS. And I think that you’re asking a very reasonable piece, which once again is what’s a compliant claim, I think it’s another piece on there. And I sort of think it should be included.
MR. ARGES: During the process of adding clarification, I think there is the issue also of claims that are in the pipeline that are submitted prior to October 16th and are developed but haven’t been processed, how to do deal with those, I think the industry is needing guidance on that.
DR. COHN: Ok, thank you, George. Ok, well I think we’ve got a draft letter together. What we will do is review it with all appropriate legal entities, we will obviously work on it, we probably will see draft versions of it, if we need to we’ll have either a conference call or we will just take it for draft discussion with the full Committee in June. Now with that we are running half an hour late, so we will adjourn and basically start again at 1:15. Thank you.
[Whereupon, at 12:40 p.m., the meeting was recessed to reconvene at 1:35 p.m., the same afternoon, May 20, 2003.]
DR. COHN: This is the afternoon session of the first day of actually three days of hearings for the Subcommittee on Standards and Security for the National Committee on Vital and Health Statistics. This afternoon we are going to be focusing on the Combined Health Care Informatics Initiative. Now that the initiative and first set of recommendations have been publicly announced by the Secretary we want to spend some time this afternoon discussing those recommendations and getting public input on the CHI outreach plans and planned portfolio. We’ve asked Jared Adair, who’s obviously the chair of the activity and lead of the activity to sort of lead the session. I think you and Gary Christopherson are going to start out with some introductory remarks and give us a view of the strategy and portfolio. I think then we have some special commenters and then it’s really going to be sort of open mic and discussion for the remainder of the time. Jared, would you like to take the floor? Thank you.
MS. ADAIR: Good afternoon and thank you for joining us today. I think that Simon gave a great introduction, we really did want a couple of purposes, we wanted to talk to you all about today and then share input from other folks, HIMSS and Connecting for Health also, so I will try not to take too much time but I thought that it would be good to spend a moment just reflecting on what CHI is so that we’re all on the same place, and then ask two questions of you and see if we can get some feedback by the end of the afternoon.
I think we’re very, we on the CHI Council are very interested and we’d like to put out there how we would like to have communication with the private sector as we move forward, and make sure that we’re both in agreement as to that approach. And then secondly, share with you, which we have shared before, what our portfolio is, what are the domains we’re going to look at and see if you agree with us, that those are the right domains, and if we’re approaching it in a correct order. Prioritization is obviously a very important thing. And then I think Gary wanted to bring you up to date on some of the activities he’s working on, turn the mics over for a little while, and then come back later in the afternoon and share with you all some very preliminary, I want to emphasize that word, underline it, bold it, exclamation points around it, some very preliminary conversations from some of our workgroups, from some of the CHI workgroups and where they’re kind of defining their domains and what some of the candidates that they see for standards that may be coming forward for selection in the future. I thought it would be interesting just to have that early conversation with you. Again, a preliminary conversation.
So let me just reflect for a moment then on what CHI is, hopefully while I can go through this pretty quickly, I think the most important thing on the CHI Council is to talk to you about the representation. Hopefully you will notice that it is growing, which is a great thing, more and more of our co-patriots within the federal government that touch health care are joining us. I think most recently we had some folks from Department of Energy, some folks out of EPA, as well as Homeland Security, so you can see that there are over 20 agencies, but I would have to say that the lead agencies who are fortunately represented here today come from Health and Human Services, Veterans Administration, and Department of Defense. And I would again like to publicly thank them for all of their contributions and efforts to make this as successful as it is.
Next I would just like to go over again some of our goals, these have been shared with you previously, most notably probably in the combined press release that came out in I guess it was March. What we are doing is that we are coming up with clinical standards, we’re adopting clinical standards that will allow us in the federal health enterprise to exchange, have interoperability, exchange data. In addition, it probably doesn’t need to be said, but Gary Christopherson is sitting next to me so I have to make sure I say it, the tipping influence, which is that as we in the federal government do these things we recognize that we are exhibiting our leadership role and it does have an impact which makes these types of conversations even more important.
Next, what is our approach, we have identified a portfolio of domains that we believe reflect the gambit, in addition obviously to HIPAA, but the gambit of what we should be addressing in health care. What we do is we deploy cross agency teams of subject matter experts to define what that domain is and come and take a look out in the industry to see what candidates there are for standards in those areas. They report back to the Council, we then deliberate on it, we sign off, we get sign offs from each of our departments.
Communication strategy, and some of this is very important, part of the reason we’re here today is that we have, NCVHS was very willing to enter into a partnership with us to help us make sure that we had a means of conversing and making sure that we stayed on mark to be candid, and we’re taking a look at the appropriate areas. In addition, another part of our strategy is that we have members, the CHI Council staff from each of our organizations, that have participated for a very long time and continue to participate in many of the private sector groups. That’s very important to us, we’re not going off into an ivory tower and making these things up on our own. We will continue to participate and that actually helps us as we form our teams together, people like Steve Steindel, for example, have the benefit of working in many of the other standards settings arenas so he really comes and is very knowledgeable in the areas and what’s going on in the industry, that’s of great benefit to us.
Ever since the public announcement about what we were doing we’ve been doing a rather significant amount of outreach and speaking in public settings and with private organizations about what our goals our, what we’re doing. We want to spend as much time as we can letting people know what we’re doing. Our goal is always as we come out with the standards for people to say yep, we knew they were doing, the standard they picked was really a no brainer, of course they picked that one. That’s a means of success, a measure of success.
Adoption of these standards, many of you have familiarity with how the federal enterprise works, we have IT architectures, we will be building these standards into our architectures and we will move as we deploy new systems, as we make modifications to our systems we will be using these standards. Our intent is not to go back and change all of our legacy systems, this is a project of where we are moving forward.
The next note on there says that we work with SDO’s when appropriate. The point that I would like to make there is that there is probably no perfect standard, and as we select standards we will find areas that need to have work done to them, and we will work with the standard development organizations to kind of say when we did our evaluation we found certain gaps, and we would like to, as we move forward, we would like to have those gaps remedied. We would like bridges to be built, we would like whatever shortcomings we had seen in there we would like to work with you to ensure that they’re corrected.
And now to get down to why it is we are here today, and I think of kind of went over these a little bit in the beginning, which is really to talk about how we gain industry input into our processes, into those workgroup processes. Again, touch base with you all about do we have the right portfolio and are we going about it in the right order. And our goal for having these two questions answered here today is the third bullet point. None of us want to get to a place at the end of our efforts, or at the end of your efforts, where we are not interoperable, where we are not compatible.
So on the next slide, clarify when is communication most appropriate, and I guess that, before I go into this let me just ask the folks I’m working with, did you all, would HIMSS or would Connecting for Health like to talk now or later, let me just verify when you all would feel most comfortable. Do you want me to kind of go through our question and answer period first?
When is communication most appropriate? As I explained earlier, our CHI approach is that we have divided things into domains. When we send a cross agency group off to start working on those domains they have the responsibility to define the domains as well as to take a look at what are the candidate standards out there. We have some choices of what we do and having our workgroups come back. Here’s a proposal and we can then just open it up and see what you think. We can have the workgroup go off, and because of all of the work that they do with the other private sector organizations, if they’re feeling pretty comfortable but there’s great clarity around that domain, that they should go ahead and work on it. If they in their overview feel like they have a lot of questions, like it’s not very clear, there’s a lot of if’s and a lot of but’s and a lot of whatever’s, that they would come back to the CHI Council and say we need some help in really defining what the lines of this domain are. And we can come to the NCVHS Subcommittee and say we need some help here, can you help us, so that would be one approach.
The other is that as they felt good about defining the domain, but when they started to take a look at what the inventory was, they didn’t necessarily feel like they know all of what’s out there, or that there were no good candidates and they’re thinking wow, there really must be some other opportunities. And once again, we could come back to the NCVHS Subcommittee and say boy, this is an important domain, we understand it, but there do not appear to be great candidates out there, we have a disconnect, help us and make sure that we’re understanding the lay of the land. Another point.
The third, which we would always do, would be to say there was clarity, we had a lot of good candidates, we have done a lot of deliberation, but before we kind of go out there we would like to come to this Subcommittee and say here’s what we’re thinking, is there something really wrong in our thought process that we did not take into consideration. That last one where we come at the end of our deliberations we would do regardless of whether there had been clarity, I should sit on my hands when I’m talking. So I may not have done the best job in describing it, but I would like to say is that if we find we’re in a situation where there’s not great clarity around the domain, not great clarity around the standards that are available, we would like the opportunity to come here and talk to you all about what have we been missing, or help us come up with instead of dotted lines, solid lines around this domain, and that would help us get clarity. Regardless, whether there was clarity or not in our deliberation process, we would like to come here at the tail end and say this is what we’re thinking, please make us aware of something we might have missed.
And this all builds on the point that I made earlier, that representatives that sit on the CHI Council, our staff spends significant time participating in other private sector outreach efforts having to do with taking a look at standards, so we do have, we are very fortunate in that we come to this proposition with already sharing a significant amount of information with those groups or from those groups.
So I’m going to stop, take a drink of water, and see what you all think. And the reason I’ve come here today is that many of you have individually called me and said we would like some insight, we would like some involvement. This is the CHI Council’s entree to that, and please let us know if it meets your needs.
I’ll always take silence as concurrence.
DR. COHN: And I guess I should probably add to all of this stuff that I think everyone at the table knows, lets make sure that everyone in the room know, that obviously the NCVHS is a statutorily authorized federal advisory committee, and therefore really the intent is to make this process as open as possible. Meetings of the NCVHS are open to everyone. When an issue comes before the NCVHS it’s really our job to get input from the industry and from the public, so that’s really I think where we fit in, trying to make sure that we’re being of help, so just for further clarification. Clem?
DR. MCDONALD: I’m Clem McDonald from Regenstrief Institute at Indiana University, I didn’t introduce myself earlier.
DR. COHN: Do you have anything to recuse yourself about?
DR. MCDONALD: Well, I don’t know how big a word, but I do have a relationship to LOINK and I’m active in HL7, and I write papers for journals and things like that. But what I wanted to actually highlight was something about the activity, maybe this hasn’t come out to everybody, that the neat part about the CHI as I read it is the goal is not to require anybody to do anything outside of the federal government. The goal is simply to demand that federal government agencies use this stuff, and the beauty of that, and I’m just reading the WEDI report here, catching up, about the struggle with standards, I mean when you mandate standards. Mandate standards, did it two years ago, but this is beautiful because you can wiggle out of things if they aren’t working. And you can get quick modifications, and plus it still will have a galvanizing effect and it won’t create this big backlash that might occur with other kinds and plus there’s no way we could figure out what the mandate for all of medical record at this stage in history, so I think it’s just, I think it’s ingenious and I wanted to give credit to the inventor of this new mechanism.
MR. CHRISTOPHERSON: I think this may be the case where you say Clem, you’re far too kind, and probably --
MS. ADAIR: I don’t know, at this point I was kind of saying have a great afternoon, I’m leaving. I can only go downhill from here.
DR. MCDONALD: The key point though is that you’re not mandating it for the whole world, which is a hard thing to do as we see because you don’t know enough.
MS. ADAIR: Yes, but we do feel like we have a responsibility, we in the federal health enterprise, because we work with a lot of you and so we should let you know what standards we’re going to be using and we’re thrilled if you decide to move with us.
MR. CHRISTOPHERSON: I think, Clem, your point was extremely well taken. When we first started out CHI there was a discussion about the issue of mandatory versus voluntarily, and it was a very clear position on the part of all of us that these are voluntary, and there were some moments we had to defend that position very strongly. And the idea here was exactly, didn’t want to go through HIPAA, we didn’t think that was the right way. We didn’t think we had all the answers, we really thought that this was going to be more of a leadership and sort of getting momentum going kinds of things, but we felt that if some of the organizations like DOD and Indian Health Service and VA as providers could live with these kinds of things we could demonstrate in our own world that these were doable reasonable things to do. And by the way, yes, as a matter of fact, they could change as time went on because they do need to change. So the voluntary nature and then the leadership, and then as Jared quite well pointed out, the issue of the tipping point really being the idea of we would surely like to get to national standards because we have partnership relationships with lots of organizations in lots of places there and we think that’s to everybody’s betterment.
MS. ADAIR: We also believe that that’s really the way that you improve standards is by having people use them, and it isn’t until they really use them in a lot of different settings that you really begin to understand their strength and where there needs to be improvements in them. And until you have a critical mass using them you aren’t exercising them enough.
MR. BLAIR: Jared, this is Jeff Blair, and when Secretary of Health and Human Services Tommy Thompson on March 25th announced the CHI standards, the announcement, there was a sentence in there indicating he it within the context of the National Health Information Infrastructure. It might be helpful for the people here to understand your view of how CHI standards play within the role of the development of a National Health Information Infrastructure.
MS. ADAIR: Ok, I’ll be happy to do that. The National Health Information Infrastructure is a concept that was put forth by the NCVHS in a report to Secretary Thompson, and I apologize for not knowing the date of that. And there are a lot of people who are working very hard because they gave a pretty high level view of what that is, and there are a lot of people working very hard at defining. But what CHI does to the NHII or for any other activity along those lines is provides a foundation, because when you get to standards, and be it clinical standards when you’re talking about CHI or HIPAA standards which is more of administrative type of data, you have the strength to move forward. It isn’t until you kind of coalesce around those standards that you’ve taken down barriers that have existed from the health care industry from really moving forward.
A lot of times when I go out and give speeches about the CHI I talk about the fact that the health care industry is on the cutting edge when it comes to a lot of its utilization of IT, certainly in its diagnosis, but all of the other wonderful attributes it brings to our care, our health care. It is not, however, on the administrative systems that support it, you would think it’s probably the last bastion of luddites that kind of exist, and one of the reasons is the lack of standards. And so what CHI does is that it becomes an enabler that as the NHII is fleshed out and as we move towards it we have a strong foundation of standards to be working off of. In my mind, that’s its relationship. Another analogy that I use is that it is establishing the gage of the railroad track. And we don’t determine in CHI whether the train is going to Boston or Philadelphia, we don’t say whether it’s going to be carrying people or cargo, but it doesn’t matter, as long as we’re all working off of the same gage we enable those things to happen.
MR. HOUSTON: Is there an attempt to try to put in place some type of measurement criteria in terms of either adoption of these standards and goals? And I guess a second part of that is obviously the end goal here is to try to improve health care delivery either in efficiency or outcomes, are there outcomes and efficiency goals and measures that you’ve also tried to establish up front to gage the success of this?
MS. ADAIR: We’re working on those goals, we are working on those measures, this is in earlier conversations I’ve had here have described this as an eGov initiative, which is under the President’s management agenda, and since it’s one of the OMB they really do encourage us to have those types of measures and we are working on those in our business case. And when you talked about the adoption, we will be, each of the federal agencies will be building it into our IT architecture and we will adopt as we come up with either new development, new systems developments or in another instances when we go through rather large renovations of our legacy systems. So it’s how it will be implemented is through those types of not going back and changing things, but your point is is that yes we are going to be looking for measures to gage the success.
Let me go back, because I want to make sure that I leave here today with somewhat of an agreement of how we’re going to have conversations, because I can’t continue to take the individual phone calls. I’m pretty selfish, and I just want to make sure you’re comfortable, I want to make sure that the people in the industry are comfortable with how we’re moving forward because we understand even though we’re not, as Clem said, we’re not mandating it to you but we understand that we do have an influence there.
MR. CHRISTOPHERSON: Let me just reinforce it. We have seen from the beginning we needed to have it, because we are federal agencies we do operate under the laws and restrictions, obviously the laws and restrictions that go along with that. We need to have vehicles, ways to communicate, and as Jared said we have lots of threaded relationships and that’s important and a key part of making this all work. But we really do see NCVHS and the people who come and appear at these kinds of committee meeting as being key vehicles, as the questions that Jared’s laid on the table, we’d lay out 24 domains, are those the right 24 domains, did we miss something, do we have something that really isn’t very meaningful, do we have the priorities right, as we start to look down the standards list are we looking at the right sets of standards, did we miss anything, I mean if we don’t have that input in process we’re not going to hit the marks the way that we want to and very honestly we’re not going to hit the mark the way you all would want us to hit it there as well, because at the end of the day I think what you’re going to want us to do is adopt the things that you would have adopted yourself if you were in our position, that’s kind of where it’s all going.
MS. MARCHABRODA(?): Janet Marchabroda, CEO of eHealth Initiative, executive director of Connecting for Health. Can we walk through how this would happen concretely? Let’s just say, if we used the last five --
MS. ADAIR: Let’s pick a domain. Does that work Janet?
MS. MARCHABRODA: That would be great.
MS. ADAIR: Ok, let’s take a domain. Immunization? Demographics. Alright demographics, let’s take it. When the group goes off, the workgroup which will have representatives, at least DOD, VA, and HHS goes off to start, we’ve given, the CHI Council has given them the assignment, whether they wanted it or not, they got the assignment to go off and take a look at that domain. And as they started to do it, they started scratching their head and saying whoa, this is not very clear-cut to us, we really don’t understand what’s in, what’s out, how it will work with other things. We’ll go back to the Council and say we need some assistance, we need to have some conversations with the private sector. We would call, it would be a little bit more organized than this, but for the sake of this one example, we would come to Simon and Jeff and say help. At your next session, your next regularly scheduled NCVHS Subcommittee, we would like to put on the agenda that we are in fact trying in CHI to take a look at the demographic domain, and we would like to have some conversations, some back and forth with the private sector, to kind of like say to them ok, when they started to take a look at this they thought well these elements are definitely in, these are out. Do you all agree with this, do you think that’s the right thing, have we missed something? So that one would be one set of potential conversations, Janet.
Another would have been, Jorge would in leading that group would have gone off and said no, we understand exactly what is in this domain. But as we take a look at what the inventory is of candidates out there, we only saw one, or we only saw two, or whatever, and geez, it doesn’t really connect to us, we really do believe that we might be missing something because we don’t have people that have been as involved in some of the other private sector things, so let’s call on Jeff, let’s call on Simon again and say we’d like to in a public setting say we’re trying to work on this domain, we went to take a look at what the potential standards out there, these are the only two we saw. Were there more? Are there things you want to tell us about? Because before we go do our deliberations we’d love to hear it. So if there’s not clarity what we would like to do is come early to this Subcommittee and say help. Tell us things that will help us shape our thought process.
Now, that’s if there’s not clarity. If there’s clarity and if Jorge when he was doing the demographics he said yep, I know, and the rest of the group, I know exactly what this domain means, I know that there are six viable candidates out there, and we will be go do our evaluation. And at the end of the evaluative process they will write a report, they’ll bring to the CHI Council, we’ll, trust me, kick it around awhile, probably painful for Jorge but ok for the rest of us. But we’ll work it through and we’ll go back and have conversations with each of the departments that we represent because as you can imagine there are very, they have many functions, they are very diverse kind of applications within it, we have a responsibility to go back and talk and at least understand what the implications are to the vast array of services that VA provides, for example. But before we signed off on it, before we made any announcements, we would come back to this group and say ok, we had a responsibility to go do demographics, here are the candidates we took a look at and here’s where we’re coming out. Is there some input you would like before we kind of sign on any line.
MR. CHRISTOPHERSON: There’s even a parallel relationship, which is that the issue comes up by the way, does NCVHS has a role both of input but also has a role of recommending, so the NCVHS actually will be both gathering information for its own deliberations, helping us gather information for our deliberations, and then we roll them back together when it comes time for a recommendation on your side, in time for action on our side.
MS. MARCHABRODA: Input, to what you just said, I think it would be helpful if the private sector had input even in that first scenario when Jorge thought that he really got it right and before he moved it through the evaluation process within NCVHS and CHI. So we’d love to see that. And the second piece that would be helpful is sometimes we don’t see, we don’t have enough time to react to documents and so providing sort of your deliberations or your conclusions and giving, because the private sector is pretty big and there are lots of people in it, and giving us some time to sort of think through it in a thoughtful careful way to provide meaningful input, whether that’s 30 days or some set time period, I think would be helpful.
MS. ADAIR: 30 days --
MS. MARCHABRODA: Or 60 or --
MS. ADAIR: I was about to go the other way. And I need to be realistic with you all. This isn’t easy because I always remember how large these sessions are. There’s great demands on us, Janet, to move faster and we understand it’s important for people to have an opportunity to have 30 days to take a look at something, but the expectations of our powers that be are, I’ll give you a kind of an example, when we went out with the first five, I was even asked the question, hey, if we wait another week can we get all 24. It was like well, no, I don’t think so. So we’re hearing you about the opportunity to have that. I don’t want to leave you with an impression that 30 days is going to be available.
MS. MARCHABRODA: The first set, we all sort of knew that was the way to go, I think it’s going to get harder, anyhow, I would just encourage longer time periods. While we all want to move to adoption quickly, for the government to adopt certain standards is a really big deal and it will affect health care, and I guess I’d just like us to be --
MS. ADAIR: In a positive way.
MS. MARCHABRODA: In a very positive way, I’m the biggest champion for standards, so I just would like ample opportunity for the folks that really understand this and are implementing systems in hospitals and labs every day to have ample time to review and provide input.
MR. CHRISTOPHERSON: Let me jump ahead to the process, there’s a couple more pieces to the process I think are probably going to answer part of your questions here. Part of the reason we’re coming here today and asking you do we have the right 24 domains is to give you a chance now to get influencing that part of the argument. The first five or six you were absolutely right, there was really, one of the reasons why we went with what we did is because we really did have, we’re getting no objections from anywhere we were doing the policy on in terms of there. The next six are not so clear in terms of that. By the way, that’s going through a longer more deliberative process there. One of the reasons why we’re coming here again today is say heads up by the way, these are the areas we’re looking at, this is the time to start looking to provide your input via NCVHS or through all these informal threads that we have there, this is the time again to try and move that. The remaining set, which is 24 minus 11 that’s sitting out there, is a much longer timeframe. There will be plenty of opportunity to have input via NCVHS to influence what those are because in some cases they’re going to be cold starts, they don’t exist, some that are in the infancy stages, so I don’t think we’re going to have nearly the problem as it seems. The first ones were pretty clean and clear, the next set have a longer timeframe, the other ones have a longer timeframe, subject to what is quite correct about Jared’s view that there are people who very honestly do ask the question she put on the table is, if I wait another week or two weeks or by the end of the summer can I have all 24. So we have some educating to do.
DR. COHN: I think Randy you wanted to comment before we --
MS. THOMAS: Yes, if I might, Randy Thomas, I’m here, I work at Health Link but I’m here representing HIMSS. And it just seems to me that there’s a lot of work, when we were talking before things got going, there’s a lot of work, there’s this explosion of activity around HIT standards, and maybe proactively HIMSS could certainly be working on this, gather together the work and the organizations that are already working on this like the National Alliance for Health Information Technology, to already bring to the table what’s been worked on as input into the further domains and the standards that are out there. I know HIMSS work with NAHIT to come up with a standards inventory, which was really an interesting process in terms of what’s already out there and what the overlaps are and where the gaps are, and as input now so that that could facilitate because I for one don’t want to see a 30 days comment period, this has taken long enough to get to this point. I want to see this go as rapidly as possible but as prudently as possible as well.
MS. ADAIR: Right. And one of the, we are anxious to get information that people have done, any analytic work that can be given to us is a God send to us. One of the things that we had, for example as Gary indicated when we worked on the first five, was that there was some significant work done by NCVHS on four of those five, and so that we I hope gave credit that they had done significant work and we were just putting the icing on that cake. And so anything that we can do, once we get off of this question and then get onto the second question of is this the right set of standards, excuse me, the set of domains, you all can say and by the way, did you know that there’s some research that you can get a copy of at this place and take a look at it. We’re very willing to work off of other people’s starting points, that just puts us miles ahead. And also gives us views from outside our own.
DR. COHN: Carol I think you’re next and then Marjorie and then --
DR. DIAMOND: Thanks, I’m Carol Diamond with the Markle Foundation and I’m chairing an initiative called Connecting for Health which was mentioned a couple of times today. I got interested in this issue not so much because I love standards, I think they’re great, but I got interested in it because I thought it was an ingredient that we needed to improve the health of people. And our organization, the Foundation works in the public interest and I would assume that many of you here today from the federal agencies feel the same way. I think it’s important to really understand that people will move in and out of the private and public sector throughout their lifetimes and that the whole reason for these standards is really to enable the delivery of health care and the improvement of their health in the way that we all want to see happen and can’t do today, and that’s really the purpose of information systems.
I went into this initiative nine months ago as many of you know sort of hoping that we could bring a very broad group of stakeholders, it’s I don’t know, somewhere between 90 and 100 organizations participating today, to agree not only on what the standards are but to take some actions in driving some of their implementation. And that first set of five standards that was mentioned earlier were clearly the initial set we identified as well in September and our steering group agree that they were the right set and we’ve been able to drive significant action with this steering group, this group of leaders, to begin to adopt them.
But I will say sort of looking back on the process that with leadership comes responsibility for the implications of that adoption and I went into this thinking that we could sort of go through a list, work on one standard at a time, and be done real quick, and I am concerned a little bit about the over simplification and maybe it’s a process issue that we need to think a little bit about. What I’ve learned in the last nine months is that standards are not a one time thing, you don’t pick a standard, nail it down, it’s over, you’re done and move on, it’s an evolving and iterating arena as medical care begins to expand, we have new technologies, new initiatives, all kinds of new things that need to be incorporated.
And then the other thing that I’ve understood is that all these standards sort of need to work together, too, at some point if we’re going to have a robust step toward interoperability. And I guess I would just ask that some thought be given to a more dynamic process for standards so that it’s not a one-time input thing. While I think in some cases it might serve the purpose to try to solicit input one time, what I’ve learned through listening to many very complicated conversation that last many, many hours over the last several months is that a lot of these issues need to be worked out and there’s a role for collaboration and solving problems and figuring out solutions that I think would behoove everyone to think as broadly as possible about multi stakeholder input.
One of the things, I’m speaking today actually because Ed Hammon who chairs our data standards working group couldn’t make it and I clearly know less than him about his and I’m not in any way going to speak for him, but one of the things that he’s at least brought back to us many times is that one of the values of having such broad stakeholder participation is that it’s created a dialogue that really hasn’t taken place before in the standards organizations or in some of the other fora for discussing standards, that because we reached out broadly we got people involved in thinking about these issues and ultimately the users of these standards, the physicians and the consumer groups and the folks who actually have to use the systems that are built on these standards to begin to participate in the dialogue and understand they’re important, and I would not underestimate the importance of that and the importance of having a dynamic process for that input.
DR. CHRISTOPHERSON: One point, coming back to you about how does this all play out, clearly the point about this not being a snapshot, one time and never gets to home and do other things, the issue I think we’re coming back to is, the work we’re doing by the way is really doing two things. In the first place what are the domains, the second is what are, when we say what the standards should be we’re really talking about actually a process, so we’re saying this may be where we are today, there’s an SDO that should be identified, in almost every case we’re going to be talking about an SDO, that we assume will play the role of taking on and maintaining a domain over time there, so that’s really what our intention is to try and do it. It’s not to get us in the business of doing it, or very honestly one time is to have an ongoing living, breathing process that allows the standards to grow, and then as new standards open up, human genome area for example is going to have some interesting world to deal with at some point in time, there’s going to be other SDO’s that come into play, there are SDO’s that don’t exist in some of these areas that we are going to actually have to look at as organizations to figure out how do we have anything to create. The position we took going into this is that we will sort of approach the world in four steps. There’d be adoption if it was ready to be adopted. There was acquisition, and some of you are aware of where we’re doing some acquisition work in that area as well. In some cases it’s going to be sort of a nudge, which is something existed sort of beginning, it wasn’t across the finish line, we will try and help them do that, using our good offices as well as coupling with the rest of you in your good offices. And then finally we will see some new starts, new starts in terms of domains that weren’t really worked on any significant way, or where there wasn’t an SDO that really existed and we were ready to say we would help bring about that to come into place. So it is a living, breathing process.
MS. ADAIR: We call it an evergreening process, that’s term, that we kind of consider that we will continue to keep it fresh and we will also have to take a look at what new needs we have. And the last part is that you brought up harmonization and we do recognize that these pieces have to work together so that we are, those are evergreening and harmonization are words that have come into my vocabulary which I didn’t expect in this way, I really did only want to think of it as a tree.
MR. RODY: Dan Rody, AHIMA. I started with standards about 13 years ago and was one of a group who kicked out of the X-12-C because no one would accept the fact that we would submit this much data with any standard. The other industries looked at us as rather weird, and we are. We are the last industry to rapidly look at and adopt standards and as you all know we are also the last industry to go electronic, and we spent a lot of time in this room and other rooms going through that, I don’t have to convince anyone of that.
But we are in the infancy, and one of the things I discovered when I went to X-12 was the motor industry really did well and I discovered that was because Ford, General Motors, and GM had a little council and they sat down and they decided on the standard and then they went to the suppliers and said this is the X-12 standard we’re going to use, if you want to do business with us this is the standard you will use. They got very good compliance because if folks didn’t follow the standard they were out of business.
We are much newer in that line, we have struggled for a number of years to come up with these standards, and so the concern I would like to address today, and it’s kind of been echoed already, is the need to have dialogue more than once or twice with the community, a concern that parts of the community could also be out doing what you all are doing and we’re going to expend a lot of energy when we could be doing it together. Concern that this Committee has got certain goals and objectives that sound to me very similar to what you’re doing, should they give up their work and let you do it and then bring it back and get it approved.
We’ve got a number of things that need coordination, recognizing that if you pick a standard, and even if we have a few opportunities to respond to the standard, the standard you pick is probably going to be the standard the industry lives with, and that we’ve got to have this coordination because there’s going to be a lot of frustration believing that you may or may not be there.
And when it comes to picking an SDO obviously every SDO in this room I suspect would like to volunteer for one or more of those standards. I’m aware HL7 right now has taken up a new project that they don’t necessarily know is their project but you’ve asked them to do it so they’re going to look at it. Fortunately I’m represented there, I don’t have to worry about it, but we’ve got a lot going on in this community and you’ve got a lot of talent, it’s not that I don’t trust that you’re going to come up with the right answers, it’s just that we’ve got some idiosyncrasies ourselves and we are an infant industry in this area, so I hope that these processes can maybe be a little more exchanged than it sounds right now, and that may be just nomenclature we’re using today and timing, but we need more than one visit a year to the NCVHS or that kind of a process to know what’s happening and how we can get input to it either through this directly or through the other SDO’s.
MR. CHRISTOPHERSON: Dan, I think, again I want to reemphasize, I’m not sure we’re completely getting the message out we need to get out. We as a federal agency have some limitations of how we can do things, it’s the nature of the laws we live underneath there. NCVHS exists specifically to bring public input into the process, and the relationship we’re sort of playing out here today is that new relationship where that’s an ongoing living, breathing relationship, NCVHS, through which public input comes in. It isn’t the only route, but it is a for sure route, it is the one that’s going to protect your interests to make sure we don’t get off on an unusual track, besides the fact that hopefully we’re smart enough to figure out how to do that.
The other part by the way is, I think you all need to look around you, when we sit down in meetings together whether it’s, you can pick your favorite SDO organization, the odds are that people in this room are sitting next to your or some of our people are sitting next to you talking next door. It isn’t like we’re off in different communities, and I think the answer is, we’ve got to make sure we keep that connection, and that is clearly the intention here. If we can send any signal strongly today is that we’re not interested in being out there by ourselves, that is the last thing in the world we want to try and do. What we are really trying to do is to try to get everyone together into the mainstream, get them adopted, what we are in many ways is a machine to make it happen. Because what’s been missing for all the dialogues, all the people I’ve known who have been doing this for 15, 20 years, is lots of great dialogue, lot of good thinking, can’t get across the finish line. Well, guess what, we’re about getting things across the finish lines, hard to believe the federal government does that, but that’s really our role. And our job more than anything else is to give you a chance to really have happen what you’ve been dreaming about for 20 years, to make it happen, and we’re the vehicle that says bring it to us, give us your best thoughts, help us to think through it smartly and we promise on our side to be responsible in terms of making the decisions and final particulars of that part. And by the way, Simon and Jeff will keep us honest, they’re quite good at doing it.
MS. ADAIR: And I think the other is that we are going to strongly continue to work with, as Gary indicated, with the standards development organizations. Now the beauty will be is that as folks in the VA and DOD and HHS go to those, they don’t any longer just go kind of with the perspective of what their program needs are, but they’ve now become a part of something that we tend to think of as a federal health enterprise and that they kind of have opened up a little bit as to what they think and what they’ve seen and what they understand the needs to be. And I think that’s also an important benefit that will go to the standard development organizations.
MR. RISHEL: I have a question and then maybe one or two comments. Wes Rishel, chair of HL7. The goal of this effort is to actually interoperate, is that correct? That is your job won’t be done until the VA and the DOD and the HHS are exchanging information on the basis of this architecture, I’m getting a nod yes.
MS. ADAIR: As business drivers.
MR. RISHEL: Well, I think that’s wonderful, and it is what is lacking in a lot of efforts which is getting it all the way to the end. It means dealing with ugly issues that HIPAA ignored, for example, like we know what data to send under HIPAA pretty well, but we don’t know how to send it. The underlying technology standards were ignored in that initiative. If a group takes as its challenge creating interoperability to the end then it has to deal with all of these related issues, often they are more difficult than simply selecting a standard.
Second point is to recognize Dan’s story about the big three auto makers. What they did was take a very general standard, design it to apply in a whole variety of situations, and therefore actually applicable in none of them, and create a very specific standard that you could implement. And that process of going from the standard to the implementation guide is always necessary to adopt a standard, there is no case where, I mean if all that I had heard was that you had adopted HL7 and some other standards I would say that was a very naïve approach. The requirement is to show how to use that and there’s a trade-off between time and results and scope, and I think it’s very appropriate for the federal government to narrow the scope to interactions within the federal government in order to proceed more quickly to that level of specificity you need. We simply have to be aware that the spillover may require adaptation as well as just spillover because the requirements identified by these specific agencies will be different then the union of all requirements identified through industry.
MR. CHRISTOPHERSON: Wes, you make an extremely important point. It’s important to look a little bit of how we got to this point, there’s a little bit of history and I’m going to come back to this later on, but let me give you a couple points of history. VA, DOD, and Indian Health Service, three separate organizations, all had between, had hundreds of different standards within their own organizations. First decision point was DOD deciding one standard across DOD. VA, one standard across VA. Indian Health Service, one standard across Indian Health Service. And then one day somebody had the smart idea to sit back and say you know, maybe we could just go to one, period, across all the organizations there, because the idea was exactly as you say, the ability to “interoperate”, to take care of patients across, to share information when appropriate and authorized to do, was the key of that. And the key about that is that you’re exactly correct about the implementation guide level, you can’t just stop and say HL7, now I’m done and get to home and smile a lot, the answer is you’ve got to go down to the implementation guide level. Simon and I have talked a lot about this issue about how we get rid of the wobble, as we sometimes refer to it there, so that you really are talking about true interoperability at the clinical level.
MR. RISHEL: I have to assume that the public health information network is somehow contributing to the overall effort, is that correct? Because I think that’s an excellent model for the scope in terms of the variety of different standards you have to make work together as well as how to take a general standard and make it actually interoperable.
MR. WAEGMANN: Peter Waegmann, CEO of Free Medical Records Institute, chair of the ISO U.S. tack five, so TT215(?) and chair of ASTM, E-31 among many others of these committees. I really would like to bring up an issue because I was the past chair for six years of ANSI HISB. We have ANSI HISB as a health informatics standards board to coordinate standards, and I missed here in the talks today free participation or at least free consultation of the official standards board we have in the United States under ANSI to coordinate and to work on that. I know that for Steve and some others there is some interaction but I would have liked today to see the chair of ANSI HISB at the table because I think it’s a major organization we should not overlook.
MR. CHRISTOPHERSON: One of the questions that we have to wrestle with, and I think you’re raising an interesting point about it, is so far we are talking about a series of domains and a series of standards within those domains. The interesting question is is how does this all fit together, and is it create a coherence of how it all fits together. And I think that’s the issue we have to still wrestle with in a big way, I think there’s something where clearly we would appreciate input from a lot of folks, NCVHS in particular, is how does this all fit together, what are we missing, I mean we’re doing it sort of on a pieces level but we need to rise up one level and say if I want to deal with, for example, in a group practice kind of setting, which is where reality is going to play itself out, is what kinds of standards would I need to have in place, what have I done essentially with phase one -- with living and breathing. Hospital setting, nursing home setting, care in the community setting, integrated health system setting, health plan setting, and by the way since in both VHA and DOD represent two of those large integrated settings along with people like Kaiser and others, at the end of the day we have to cover all those territories. But there is a sense of how does this all fit together, what’s the whole sort of look like and how does it fit together, and that’s something we really do need lots of input as we can possibly get on how to do that.
DR. COHN: John and then Marjorie, did you also want to comment? John first.
MR. HOUSTON: To reiterate something that was said a little bit earlier, I’d actually expand up on it. I know one of the things that sort of fell off the security rule under HIPAA was e-signature and I guess I’m sort of looking at even a layer below I think what seeing I guess is coming up, wondering where’s things like authentication and electronic signature and some of the things I think necessary pieces to glue all this together and allow interoperability to work. Where does that fall into this because it’s great to have standards but as I see at least within the health care environment I work in that often the thing that prevents things from working together is the fact that you don’t have a common authentication capability or some standards that will allow these systems and allow these environments to trust one another. And again, electronic signature to me is if you’re going to start to pass documents around and assume that the electronic version is in fact true and unadulterated, you have to also have some confidence that something couldn’t have changed. I’m wondering how that fits together in this schema.
MS. ADAIR: A couple of things there. The first is is that as you point out maybe one of the things we need to take a look at when we come back and have the conversation with you about the clinical encounters, some of that will be addressed. And the other is is that we will be taking a look at, you know when you talk about authentication, we will be dependent upon what some of the HIPAA security, with the HIPAA security and the privacy, I mean when we’ve talked to you all previously we’ve said that we will in fact be dependent upon those rules to carry forward.
MR. HOUSTON: I’m not sure there’s even enough detail for what you really need for it to happen to do some of those things under security, I think you almost want to set some fairly, I don’t want to say concrete but actionable standards or how you authenticate, and I know it’s getting into a level of detail that maybe you’re not prepared for but I think it’s absolutely vital.
MS. ADAIR: I want to allow Steve to say something here in just a moment, and it could just be me, you’re moving onto a point that I’m happy to have that conversation, which is is it the right set of domains that we’ve set out there, and are there holes and are there things we need to think about. I’m kind of, people will tell you it’s kind of like I’m a little bit like did we finish the other conversation, I want to make sure I come to closure about that a little bit about how we’re going to have conversations before I move on to is this the right portfolio, do we have the right domains, and are there issues that people would like to bring up. And I apologize, it could just be --
DR. STEINDEL: Jared, may I just make one quick comment because it will sort of do what Jared does. When we started CHI one of the first assumptions that we made was that when it comes time to look at those important areas, other areas of health care, that the first thing we would look at is the other eGov initiatives that are working in those areas, so CHI has not started to look into those areas yet.
MS. GREENBERG: Much of what I have wanted to say I think has been said by others, but I still think I’ll just make a few remarks about how people might think in terms of interacting with the National Committee, having spent a good part of my career interacting with the National Committee. I think as Gary and Jared have made clear, and as Clem suggested, if this were sort of of the HIPAA model where you’re going through regulation and if you look back on that, there could be lots of hearings, and there would be, and there would be a long time period and there would be more probably input, there would also be input through a comment period, etc. But, this takes a long time, and of course the National Committee did have a role in that whole process as well. But there are some limitations in the Federal Advisory Committee Act to actually include non-federal folks in an activity that is strictly for the government. But I think if you look at how the National Committee can interact with that it already was mentioned that the first set of standards were adopted, really came very much out of the recommendations, the message format standards, of the National Committee, which involved lots of hearings, lots of input. And there’s no way we could have come to closure on those or we’d tweak them a bit but without that work.
Somebody mentioned demographics, well the National Committee has done work and made recommendations related to demographics, essentially over a period of about 30 years, but most recently in the core health data elements, which involved a few years of hearings, a lot of input, a lot of back and forth, and that of course came to bear and was looked at as part of looking at how do we define the demographics domain. So I think that right now the National Committee is doing, in these three days, doing a lot of investigation on terminologies, and again, I think there’s been and will continue to be a lot of opportunity for input on that, a lot of back and forth, people getting time to review things.
And I think at the end of the day as Jared suggested, so we have all of that to help guide the work, but even then at the end of the day, when the CHI Council comes forward with either preliminary recommendations for the National Committee or more ones that they feel, the Council feels quite confident about, this is still an opportunity for the National Committee to really function as it does best, which is bringing the public and private sectors together. And I think that even though this effort is under a lot pressure from the eGov initiative to move things quickly, if the Committee gets, both provides the advice and gets the advice from everyone in this room and beyond who participates in the meetings, that this is just premature or that more works needs to be done, I think the Committee will be very blunt about that. And I think that that will be heard in a way that it would not perhaps be heard if one group or another said gee, we’re not quite sure we like the way you’re moving.
So I encourage you to really see the Committee as your voice for that because I think that at the end of the day if the Committee says whoa, or we just think this needs to be done or this needs to be looked at, or you’re moving too fast, the Council will certainly will hear that and those who are kind of directing the Council will also hear that. So that’s a bit of a pollyannaish approach but I think that just because you’re not on the National Committee or maybe usually don’t comes to the meetings it’s not a reason not to really see this as an opportunity to use the Committee for that kind of input.
MS. ADAIR: I think at this point I’ve gotten, I and the Council have gotten a lot of input and we may feed back to you what I’ve kind of heard, we’ll go back and we’ll have conversations again with Simon and Jeff about what I think I’m taking away, is that there is a question about the frequency. And whoever said once a year I just want you to know this is the third or fourth time I’ve been here this year, so I’m working on 2008, so it won’t be that bad I promise, but we will take a look. And another thing is that we today will go over with you the entirety of our portfolio, so that to a certain degree puts you all on notice of what we’re going to be looking at, what our work plan is, and as you all have offered, if you have material, if you have things you would like us to be taking a look at that will give us something out of the starting gate on some of these domains, please get them to, I don’t know if you get it to Marjorie, Simon, or Jeff, whoever the right person is, if you can get it to them they will get it to us and we will use it. So that’s, I really do want to get to the portfolio because I think that that kind of gives you, allows us to get into a little bit more of the specifics and maybe does my little heart good because I’m kind like said, this is our work plan, and we will put a work plan out there. Do I think it’s an aggressive one? Oh you betcha.
DR. MCDONALD: I just wanted to comment on the idea that this is an infancy. If this is an infancy I can remember that some babies were doing this in 1984 and that we’re really at least into our long adolescent years, and that I think in many other, that I think it’s not bad to have someone pushing over the finish line before some of us previously infants are dead.
DR. COHN: I was going to say, I think you were one of those infants in 1984, weren’t you? Well said. Ok, shall we move on to the next --
MS. ADAIR: Oh good, I’m glad I don’t have to comment on that part.
Ok, so that’s the input we’re taking away kind of on the question of the conversation. So what is the portfolio. We’re showing it on a couple of slides here. The first is we’ve identified 24 messaging and vocabulary domains, we have to date probably no great surprise to any of you adopted four messaging, one vocabulary standard. We now have six vocabulary teams working and on the second part of our agenda this afternoon five of those groups will come and have their again, preliminary conversation with you all so you can see what we’re thinking about now, and we are starting to form teams on the rest of them.
The next slide reiterates the point that Gary brought up earlier which is we recognize that standards are at different points of maturity and so when we say adopt, please know that we recognize that there are many attributes that will surround it. Some of them will be it’s all ready to go, some is that we’re going to need to nudge, some of these, I’ll be candid with you, we readily know when we take a look at some of these domains, there’s going to be nothing there, and we think that’s a valuable thing to come back to you all and say we had this domain, we really wanted to adopt a standard, but there was nothing there, and have the industry bring to bear their power and their resources to come up with a standard. And then also as Gary indicated, there are various acquisition strategies and public availability issues.
The next, there’s a work plan, and many of the folks that we work with would tell you that that’s too slow. We have an ambitious goal. We would like in the 24 to have at least had broad inclinations, indications of where we’re going by the end of the year. Again, I want to reiterate, some of that could be we wanted to pick a standard but there wasn’t one ready.
The next slide says, I’m not going to spend time on it, it’s there, we announced it, it was in the press release, those are the five standards. The ones that we currently deployed are demographics, medications, interventions and procedures, immunizations, lab result content, clinical encounters. Just to kind of go through so you see the whole portfolio, the next ones coming up, diagnosis/problem list, history and physical, text-based reports, population health, physiology, multimedia, nursing, genes and proteins, and supplies. And in case you’re wondering how we get to 24, you would add to that financial/billing, chemical, disability, and unit, but obviously there are most notably and because of the other hat I wear which is HIPAA, on financial and billing for example there are rules established, standards established under HIPAA, and we’ll merely need to validate and potentially harmonize in these areas. That is the portfolio, that is the priority we’re going to be following.
MR. CHRISTOPHERSON: Let me build off Jared’s point here. We recognize, I kind of go back to your point earlier about the security areas, there are areas, this is primarily the focus of our vocabulary and messaging and those kinds of things, and it hasn’t gone to some other areas yet as well, so clearly there’s probably going to be some areas in security or issues around for example e-signature that need to come into play, so this portfolio is still a living, breathing portfolio. There clearly are discussions going on about for example, do we need to do something in the functional area around electronic health record as a sort of a different cut, a different view of this kind of thing. There’s early work that’s being done for things like personal health records, there’s going to sometime be standards in those areas as well. We have to take a look somewhere down the road around information exchange, do we have all of the standards identified in those areas. So again, to understand that this is the 24 that we’re dealing with right now, there are other areas that we’re already thinking about that we are probably going to have to make moves into as well to sort of fill the portfolio out before we’re all said and done.
MS. ADAIR: We draw a picture, and it may not be the best picture in the whole world, but it shows a continuum of health care and the picture we show on the far left hand side is the administrative data which is governed by the HIPAA. And on the far right is the clinical data, and we recognize, please know we recognize that they come together in the attachments, that there are issues that do cross, that when you adjudicate in a claim and sometimes you need additional clinical information and we understand that relationship. What we’re trying to address in these 24 domains is the right hand side. This is our first cut at it. We developed this as a CHI Council, and again that’s a federal health enterprise and we come at it from a lot of different roles, DOD and VA come at it very specifically with as providers of care. And we pay for care and we use data from a research kind of point of view, so we have a lot of different roles that we look at it and this is the domains we came up with.
DR. COHN: No I was just going to comment back to John about this whole issue of e-signature, which actually by the way actually doesn’t even have to be a CHI activity, it’s actually part of HIPAA. And if you’ll remember it was part of the security rule and then got pulled out, there was actually some work that we asked to be done by the standards groups to try to come up with the standard and this sort of was very active for a while and we have not heard from them recently, so this is once again a statement that something like CHI might help us get to the finish line on some of these things.
MR. HOUSTON: I’m trying to look at practically, too, in terms of looking at tele-health types of initiatives, and there’s so many things that if you want to make tele-health, and I know it’s of great importance to the Department of Defense specifically of being able to tele-health type of activities, and some of the things I sort of spoke to are things that just stand out in mind, and it’s not even so much regulatory and HIPAA as much as it’s trying to practically look at how do you get to the end goal, there’s so many things here, you need to have them structurally to make all this work and work well. So again, maybe I’m speaking out of order but I’m really interested in trying to see all the pieces sort of come together at one time because I think they’re all indispensable at the end of the day.
MS. ADAIR: I don’t disagree, and I guess somewhat of it goes back to Jeff’s point of the NHII, and that those are all attributes in there. And I’m not saying this is a pointy head bureaucrat, I’m really not, please take this is that what we’re trying to do is hold our scope, because if we hold our scope and we get through that and we’re successful, then we together with parts of other groups or whatever, can move on to that next kind of a challenge, and that if we keep adding on to our scope and don’t come up with these, we’ll never move forward. So there is a side of me that says ok, the scope is to come up with these clinical standards, and they will in fact enable and they will draw all questions as you so aptly put on the table. But before, we’ve got to get these standards done, that’s the scope.
MR. CHRISTOPHERSON: Let me reinforce Jared’s point because there’s another piece to this puzzle, there’s a 100 percent solution sitting out there somewhere which none of may ever live long enough to ever actually see. What is really critical now is how we deliver essentially the 70 to 80 percent part of the solution. And so what you’re really seeing in CHI is driving very hard to get that 70 to 80 percent of the game. I think there’s, a lot of people look at it if we get through possibly even the first 11 of these things, if these are the right first 11, we are probably going to be pretty close to having a pretty high number of percentage of covered, of things which they actually deliver health care on a day to day basis and in a way that allows the interoperability going back to the point made by Wes earlier on.
DR. DIAMOND: I congratulate you on the ambitiousness of your list and of your timeline, kudos, it’s great to see. I have one question related to some additional specificity, is there anything addition you could say about what’s in the demographics domain? Is there any more specificity you can provide?
MS. ADAIR: I think that later this afternoon Beth will be talking a little bit about how we’re defining that domain, it’s one of the, just to let you know the five that we’re going to in a preliminary way have a conversation with you today, Cynthia handed me this a while ago I guess because I was supposed to have read it, lab result content, medications, demographic, immunizations, and interventions and procedures. We’ll kind of talk a little bit about those five today.
DR. BICKFORD: Dr. Carol Bickford from the American Nurses Association, I have two questions. One of them is I don’t see outcomes identified anywhere in your listing, and if we’re thinking about clinical decision making and evidence based practice and accountability and valuing, where’s the outcome stuff?
DR. FERRER: Carol, I can take a little stab at that, we are looking at clinical terminologies, not code sets for billing, so our intent is that when we choose the domains that they are clinically supported so that data would be at the level, of the correct level of abstraction, that way we could do sort of the outcome based analysis that you’re talking about. That’s implied perhaps, not in which represented, but that’s sort of where we need to be.
MR. CHRISTOPHERSON: There’s two parts of the outcomes question. One is we have the terminology and the standards to of course see the outcomes kind of analysis, the answer to that I believe yes, to what Steve and Jorge just implied. The issue was what should be the outcome measure itself and a measure of whether that’s success or not, that’s not really what this organization is really about, that’s other places will play that part in deciding whether this is an adequate level of patient outcome in terms of ability or whether it’s cardiovascular, pick your favorite disease category, or health measure on that line. That’s a different organization that deals with that part of the issue, that’s not what we’re dealing with here. Ours is the key to provide the data necessary to support and saying did we meet it or not, did we make that outcome or not.
DR. BICKFORD: I guess I’m raising that as a question from the extensive work that nursing has done in identifying outcomes from the standpoint of patient changes over practice. What happens when the intervention occurs, is there’s a difference that’s made at the clinical level, not at the dollars and cents piece, that dollars and cents is attached to it. So I’m a bit concerned that we don’t have a measure identified there and if there’s another organization doing it who is that, with a standardized code set so that we have an understanding of, for example, Lycrat(?) scale from zero to five is the measure that we’re using for our outcomes.
DR. FITZMAURICE: Let me jump in and say that a lot of that is part of AHRQ’s work and a lot of the research that ARHQ has funded has been just in developing the quality measures. A lot of the standards have not yet matured so that they have adopted the quality measures. There’s been quite of research that still needs to be done on it. Yet, we do know quite a bit about quality measures, there is work that needs to be done. Your point may be how do we get the existing vocabulary and terminologies to tie in with the quality measures that we have to have. For example, NCQA has said to us we have many more quality measures that we would like to adopt for HEDIS but it’s very expensive to go out and pull that out of paper records, if we had standards that allow us to accumulate that information then we could it more efficiently. Is in the area that you’re going, Carol?
DR. BICKFORD: I’m speaking in reference to how nursing has identified the terminologies that have the diagnosis interventions and the outcomes so that all three are woven together so that there’s an understanding of the clinical activity. So I’m just raising that as a question for consideration. I don’t see the outcomes pieces to help us value. If it’s there, that’s fine, but if it’s going to be popping up in all the sections, help us understand that.
Now the second question I have, if you want to answer that further that’s fine, the second question I have is it seems as if there’s an overlap in multiple areas and how is that going to be addressed. For example, you have text based reports, you have history and physical, you have clinical encounters, you have lab result contents, they all sort of fit together for various pieces and how do you chop them up to be discreet domains?
MS. WARK(?): This is Cynthia Wark and I’m technical project manager with the CHI Initiative, and if I can go back to the first comment on the nursing outcome measures. I would expect that the standards that have been identified by the nursing community and are available in the NOC standards would be one that the nursing group would look very hard at and make a determination about whether that was mature enough or had adequate content enough to adopt across the federal health enterprise. So I think that we have a process in place to address that. And I think you’re really talking about harmonization, and again, as a nurse informaticist I’m quite well aware of some outstanding work that’s been done in the nursing community to harmonize work among various vocabulary sets such as diagnoses and interventions and outcomes, and that really, that type of work really serves as an excellent example for us of how to do the harmonization across all of the domains. Of course we cannot certainly extrapolate harmonization from one specific domain across all others, but it does give us a good example, and a good test bed of how to do harmonization well and it’s certainly something that we look at across all of the domains as the teams do their work, we begin to assess where is the overlap, how does it overlap, what is the impact, and we will begin to tackles those kinds of discussions. For instance we are beginning to have, again, very preliminary discussions about how the coordination works between HIPAA and the demographics area, so that’s just an example, it is an important issue, and we will be working on that.
DR. MCDONALD: The outcome business is a very complicated business and I appreciate there’s nothing labeled there, but there is some of this computationally, I guess that’s a whole other complicated subject. But the categorization of these does make me just a little nervous, the next six, because they’re not bound down to anything that makes people understand what they are. Now how I interpret these is demographics is the field and registration record that says what the race is and gender is and things, but I don’t know that. And I interpret medication as what’s the field that says where the medication order is dispensed is. And I guess since you’ve already adopted HL7 as a messaging standard, mightn’t it be useful to sort of at least give reference to sort of specific fields so people can get context to what these are. I think you really have them but I’m guessing at what these things mean for sure.
DR. HUFF: I’m not sure if this is the right time to bring this up but I didn’t see it necessarily on the agenda so I’ll say it now and then if there’s a better time. I want to just build a little bit on what Wes Rishel was talking about and think about the next step, so this process is going on and the assumption is is that as new projects happen in the government these standards that you’ve adopted will be implemented in new systems creating increased interoperability. And a necessary step in that is a bunch of work to refine the standards to your particular needs, essentially to make implementation guides or to do other kinds of things, and in an ideal world what would be wonderful is to have that work shared back. For instance if we were talking about HL7, which you’ve already adopted, if specific messages and implementation standards surrounding that came back to HL7 so that HL7 could then review, adopt, modify those things and make the implementation guides themselves standards, that would be a wonderful way of continuing the cooperation after the selection of these terminologies. I wonder, is that the same kind of thinking that you’ve got about this or how did you hope that would work?
MR. CHRISTOPHERSON: Nice softball. The only question is I think is how we get there, there’s no doubt at all we would like to come a common set of implementation guides that we use, and by the way we would hope others would use. I think the question would be, does it come from us or does it come from people in the HL7 community, or does it kind of come together by us working together in those kinds of things. I think it probably should be no worse than us working together. I think very honestly as Simon and I have talked about there, is if HL7 can hand us tomorrow an implementation guide from one of the 2-4 version, whatever this kind of thing there, that very honestly would be extremely helpful to us, rather than us having to recreate it. We’re not looking to recreate stuff we can avoid doing that, we’d really much rather get into the adoption mode and dial the implementation guide level. So I think one of the dialogues we have to have, and HL7 is a good one of those neighbors there(?), let’s think through what’s the best way to get home, and get the wobble out, get the implementation guide level, share some work back and forth so that we’re not duplicating each other, there’s just too much work and too little talent to get this all done.
DR. STEINDEL: Stan, if I could pick up on this, I think we’re all familiar with what’s going on in the outside world. I think we need to realize that Connecting for Health is going to be publishing a set of implementation guides that are using HL7 and using some of the standards that adopt by CHI and I’m sure CHI would look at the Connecting for Health implementation guides as something to be used within the federal sector. I’m not saying since we haven’t looked at them whether we will accept them as is or change them or what have you, but that is the way we envision the process working.
MS. HUMPHREYS: I just wanted to get back to Carol’s point and just to reassure her that there have been a lot of discussions that the next set of things do seem to overlap, and how are we going to define those, and are some of these things even reasonable to consider as a separate domain, I mean there’s no point in not telling you this, but this has certainly come up on more than one CHI conversation and phone call, so I think the issue was identifying things where there were agencies within the federal government that wished they had something right there that was called that, that did that, and those were all considered high priority but when you’re through at the end of the day, yes, there is considerable overlap so how those actually get sliced and diced and defined when people start to work may be a little different than the way it looks on the piece of paper.
MR. CHRISTOPHERSON: That’s correct there. I think the other part by the way, we clearly are looking to get to non-duplicative, we do not want duplication, we really want to try and get that out of there. The question how to do that, given the fact it’s not exactly how the standards have been put together in some of these different areas, and the fact that we do have some tools that carry bits and pieces of a lot of different standards, I mean we’ve got to sort of work all that stuff through. So again, that’s where again input from NCVHS, input from the larger community will be very helpful to us.
MR. CUNNINGHAM: I’m Carl Cunningham with the American College of Physicians, I’m left over from the morning session a little bit and I’m feeling very, very uncomfortable standing here right now because I had no standards background, I had no clinical background, I assist physicians with the management of their small practices in our association. As I said this morning, we’ve got 115,000 members, 70 percent of whom are in practices of less than 20 physicians. And what’s making me uncomfortable is that you’re talking about setting some standards for the things that our small practices do every day. I’m not sure whether, to what extent this impacts them but I have enough awareness of what the limitations are of those small practices and I have the advantage of having had about a 25 year career in the federal government before I came to this association and started, and before that managing medical practices. One of the greatest shocks of all was to find out what the limitations were in terms of resources and staff support and anybody that investigates anything when I first stepped into managing of a five physician neurology practice. And I know a little bit about the composition of NCVHS, and certainly know a lot about the composition of the federal government, and I’m wondering where does the voice of those little tiny practices come from that represent how Medicare is delivered throughout this country. Is there a place? And I’m not even very comfortable suggesting a way to get that voice in there because I represent one association, there are a number of other associations, even in primary care let alone the specialty care as well, and yet all of them could be impacted by the standards that you set in the federal government based upon a large institution approach. I don’t know quite where to plug that in and maybe there is already something and if there isn’t I guess I would just ask that somebody give some to thought to that. I just happened to be here today otherwise we wouldn’t be represented even sitting here in the audience, and I don’t see any other physician, except MGMA is here, which would help some.
DR. MCDONALD: I’m a regent of the ACP so I’ll help you out a little bit, but the other point I wanted to make is this is not proposing standards for office practices, this is proposing standards for the big organizations within the federal government. Earlier I would propose that small practices would be, it’s impossible for them to get clinical data into a computer system in their office today because these standards that they’re talking about haven’t been implemented widely enough, so I think they’ll be some major advantages to these things to get stuff from outside, not for them to send to someone else.
MR. CHRISTOPHERSON: By the way, we are very sensitive to that, there’s a lot of discussion with that right now about how to, in fact actually, interestingly enough actually the greatest concern right now of CMS and us is the small practice, and trying to figure that out, and there really is, what we’re sort of hoping and a matter of fact we’ve been encouraging is organizations like yours and AFP and others sort of help us get together and work with us to try and think not only about where in the future the electronic health record is but also input into standards. So it is very much in its infancy stage but there is a great amount of concern about do you make it work in those environments. And part of that goes back to the belief we have is that a lot of the future in where we’re going with health care is going to be very dependent upon exactly the type of practices you’re talking about out there, and if we don’t figure out a way to work together on that we’re going to miss the boat and we’re not going to get done what we want to try to do. So the answer is early stages here, very cognizant of the issue there, understand it’s a very different set of practices in the austerity of the practices out there, clearly are looking for a lot of opportunity to work together with you all to try to figure that out.
DR. DIAMOND: I just wanted to correct the record on the point about the implementation guides. There were implementation guides released last week by ACDC which were developed and publicly released for public health purposes, but implementation guides to my knowledge, I hope I know what’s going on in our initiative, but to my knowledge they’re not being developed in Connecting for Health. It is, however, an issue we have heard about and thought about since the day we started it and I’ve been educated by Wes and others about the importance of them and the fact that they do need to be use case specific, and the fact also that they are expensive to do, they are costly to do. And I think it is one of the issues that we still have to, in this whole, beyond saying this is the standard in the whole adoption phase and implementation phase I think it is an open issue and it does need to be grappled with. We don’t have any solutions, I know that where we thought the conversation might be most productive on this issue was that potentially there could be developed a standard for the implementation guide, so some standard content that would be an implementation guide, so that there would at least be some consistent across the way they are developed and written, but I just wanted to correct the record and raise that as an issue that still needs a solution.
DR. COHN: Carol, and then speaking for the NCVHS as early as 2000 we sort of identified that really the implementation guides as well as conformance tests, which is the other piece of all this, are really critical, be it version 3.0 or even your favorite version 2.X, if we’re really moving towards interoperability. So I absolutely agree with you and I’m sorry that you didn’t release them all last week.
MS. THOMAS: Thank you. I also, in looking at the fact that these standards are going to be adopted in the federal sector, I mean certainly many have echoed it here today, it’s going to be a strong suggestion to the private sector and that in terms of standards adoption, which isn’t such a bad thing. But the reality in the private sector is that we’ve got a multiplicity of commercial packages out there that are in various stages of development and installation, and in various types of organizations, and that I just want to suggest that one thing that we might be able to look at is utilization of a mechanism called Integrating the Health Care Enterprise, which is taking standards that exist and showing in practical demonstration projects the ability to use those standards in real settings with real commercial applications to achieve the objective of interoperability, and that this can be done in a way, because the whole objective of looking for the adoption standards in what’s already out there, is focused on the improvement of health care and being able to feed data that’s used in outcomes analysis.
MR. CHRISTOPHERSON: Going to back to the point. First place is there’s a time aspect as well. When we say, for example, I’ll use the case of the federal government by itself, we adopt the five standards. We didn’t implement them the next day. DOD, did you get them in the next day? I know we didn’t get them in the next day, so the idea is that in the first place there’s a time aspect to this thing, which the idea of going back to, that’s been raised earlier, as new systems come on board, new software applications are written, that’s the time to sort of bring them in and bring the standards in, not trying to do a full start and hit them all on the first day out there. And by the way, yes, it’s true, hopefully a lot of these standards we’re seeing where there’s already is existing use, if it’s going to be standards we’re going to be adopting, odds are it probably should be out there somewhere being used in the real world and we’ve got to learn from that experience, hopefully it’s more likely to be done in the private sector probably than it had been done in the public sector but that’s how we’ll play through. But yes, we’ve got to sort of work this through together to make sure this really does what the end game is all about, interoperability to improve health.
DR. COHN: Ok, I think both Carol and then Jeff, and then I’m going to suggest we actually take a break. How does that sound?
DR. BICKFORD: Dr. Carol Bickford, American Nurses Association again. We’ve been talking about the United States as the cohort for this discussion and the federal government taking the lead in putting this altogether. What mechanism is in place to assure that we are in consideration of the international community? We’re having that discussion with ICD-10 even though it’s been out there in the real world and the U.S. hasn’t joined yet, so what’s being done to make sure that there’s consideration of the international initiatives in the standards area?
DR. STEINDEL: I think from a CHI point of view we’re focusing on the federal government. I think we’re trying to get somebody to address the question of international harmonization at the June NCVHS meeting to start thinking in that area, so the question of international harmonization has been raised at the NCVHS level.
MS. ORVIS(?): This is Nancy Orvis from DOD. I’d say in one context we operate world wide, certain of your federal agencies operate in a world wide environment, and so in that context in our considerations of vocabularies, those questions will come up. Can we use this in a environment where we may be collecting data from all over the world, wherever that health care is being given at that point in time? So as much as we can we will do that. In past years we have personal experience with trying to do things like that with proprietary vocabularies that were only allowed to be used in the United States, and having systems that had to operate in different parts of the world without those. So just be aware that given the missions of the federal agencies in questions we will consider international concepts as much as possible where it’s pertinent to the mission of health care.
MR. CHRISTOPHERSON: Reinforcing Nancy’s point, it is clearly, just as we have talked about the tipping point issue in the U.S. in terms of national standards, it is clearly in our interest to “be a system within harmony with what’s going on internationally” as well. I think a lot of the folks who were involved in working these standards here do have connections to some of the international standards communities as well, so again, that’s part of the input I hope that we’ll get through this process.
MR. BLAIR: Well, Carol, I think your comment about whether we’re considering international standards is extremely appropriate. Ironically enough, the comment I was going to make before you made your comment was that the domains that CHI has was influenced to some degree, in that Steve Steindel was present when the NCVHS meetings were convened in August, where we were widening up getting some guidance from the community at large as to the scope and criteria for selection of the PMRI or CHI terminologies, HIPAA PMRI terminologies, and we included among the criteria for both the message format standards and the terminology standards how these standards related to international standards, were they international, and in fact as we take a look at the terminologies that we’ve been looking at right now, I think I took a look down and saw that most of them actually either have groups, international chapters that are represented or are ISO standards, there’s two of them that are actually ISO standards, and others that have international components, so I think it’s a very valid and appropriate question and we do need to make sure that the standards do have consideration for its international applicability.
MS. ADAIR: Simon if I could just ask, because we’ve got, in the second part of the session we really did want to go over five of the ones that we’re working on and so before we take a break I would ask Carol or Randy if you wanted to make any other comments or any presentation parts of if you felt comfortable with --
And then the only other that we wanted to do prior to moving on to the workgroups is Gary, did you want to do your presentation once we get started then before we go into the workgroup?
MR. CHRISTOPHERSON: I have a feeling there’s a bodily function necessity thing that may be playing out here.
MS. ADAIR: But I feel like, let me just close up the portfolio then conversation. We will go over the five that we’ve been working on, our workgroups have been working very hard and the CHI Council is starting to work on. But this is what we’re working on, this is the domains that we’ve put out there and so if you’ve got ideas that we missed something, you think we’re in the wrong prioritization, we’re anxious to hear that and we’ll take them under consideration. We’ll make sure that we address the outcomes issue that has been brought up, and implementation guides is something that we need to, we’ve spoken about, we need to get a policy out there so that people understand what it is we’re going to be doing.
DR. COHN: Well with that let’s take a ten minute break, and we’ll be back at 3:20.
[Brief break.]
DR. COHN: Ok, Jared are we going to go through the HealthePeople presentations?
MS. ADAIR: I think that prior to going to the workgroup Gary Christopherson has asked to have a few minutes to go over some activities that the VA is doing, I think utilizing some of the standards out of the CHI project, so I’ll just turn it over to Gary.
MR. CHRISTOPHERSON: What is useful to do is to understand what we’re doing right here in standards fits into what else is going on, so part of what I’m going to try and do here is to sort of set some context of how at least some of us are viewing this thing. And again, this is not a CHI presentation as Jared will quickly point out to you, this is really trying to set context into which CHI and other things fit into here.
And I guess what I want to go back to the first thing is that we not lose sense of somehow this is about standards, this isn’t really, this is really about how do we improve, optimize how we deliver health care and how we essentially maximize how we deliver health, and how health outcomes occur. So that’s what this game is about, it is not about standards per se, standards is a very important tool to get there.
In order to set that context there I think I want to go back a little bit to how we actually are doing care today and where standards are going to help us down this road. In the first place, today we’re primarily an episodic based system. We can all talk about how we do a good job in taking care of enrollees, and how we take care of populations, but I’m sorry, the last time I checked we don’t none of us do a very good job compared to what we really need to do in the future. So the first place you ought to be looking about is how do we move from just doing episodic care, and hopefully doing that well, to being more person oriented, how we actually take care of the person from enrollment through the time that they disenroll or the time they enter a practice to the time they leave the practice, however one wants to define those kinds of things.
The third thing is that’s not good enough either by the way, we can’t just focus on the person by themselves, we need to start looking at populations. A classic case in the VA system, for example, we historically have been an episodic based system, once in a while you consider us to be a good person based system, but if you said well, how’s my panel doing, or how is a population of spinal chord injury patients doing, or how is a population that essentially have abnormal test values of a certain kind, we would have great difficulty producing that out of our system. The future says you better have the ability to try and do that.
We also better start looking more and more at the issue of how we take care of the well patient and the custodial patient, those are the two we don’t do real well with on either end of the spectrum. If we’re going to try to do all this, we have to remember, by the way, it isn’t just about IT, it’s really about how we do we take all of this best practice work that we’ve all been talking about and we publish once in a while or we put up in a website and wonder why people don’t use, but if you’re going to do this it isn’t just about IT, it’s really about how to try and deliver better clinical and other kinds of health care practice. The health and IT is an important part of delivering this whole thing but again, another piece of the puzzle, and it’s not just IT. If you talk about monitoring devices in the home, which are not IT, we could talk about all the kinds of devices we’re using in clinical and in-patient kinds of settings there, but we really haven’t sorted out how to figure out how to put this all together.
And the final piece to the slide here is really to talk about if we started to put all this together, and including the standards which help us to enable that, then we have a better chance of delivering systems out there that are better on access, better in quality, better on affordability, producing better outcomes at the end of the game there.
Now I want to go back a little bit, this is something that, there was a meeting back in October of 2001 with IOM, Kaiser, and they were kind enough to invite a bunch of other of us folks to meet with them. And we started to talk about what IOM had proposed to do, which was to become paperless by 2010. And the question was how would we get there? I think there was a clear sense there was no game plan, there was no clear sense we were going to make it, and really no clear sense about what would the necessary events to occur in terms of doing that. So what we have up here essentially is we said one thing we probably should do, by the way, is have standards. We ought to do something to make that actually happen, not just talk about it but actually make it happen. The second part we said we ought to have, we ought to have a good electronic health record systems out there. If we did those two things we’d be well on the road to making that 2010 framework there.
Now I’ve added since that time, since I think we’ve all gotten a little smarter, we all spread our horizons a little bit more, we started talking about personal health record systems, and we started to talk more about the exchange issue, which is how do we move information from place to place when authorized and appropriate to do that. So the idea was, so we said if we did that that as a matter of fact we have a shot at 2010. And I think we walked away from the meeting thinking gee, that’s a nice conversation, yes, it would be nice if it would happen, but there really was no sense that we actually were on a path to do it, we didn’t talk about how we’d actually execute that strategy, and so how do we get it adopted by health organizations, how we get people involved in this discussion as well.
Well I think the good news, and really the point I want to make more than anything else here in this part of the presentation, is actually we are on the path that we kind of hoped would happen, which is that by 2004 we would actually see major things occurring out there that were on the path to 2010. The discussion we had a few minutes ago is part of a “going beyond the talk stages to the doing stages”, and I’ll lay out some stuff in health records area that I think also points in that direction of how we are well beyond that.
Personal health records, we’re not quite so far down that road, information exchange, kind of yes and kind of no. If you’re going to try and make this work then the pieces of the puzzle have to start to fall into place, and these are some of the kinds of the key pieces there. You have to electronic health record, people will argue that you can, if you’re going to do anything at all about the rest of that you have to start with a good electronic health record inside provider organizations, so that’s what drives almost everything else we’re talking about. PHR, personal health records, are a nice discussion, but very honestly if you really want to make them work you better have a good system to start with in the first place.
And while it may be very nice for you to have one, if somebody else doesn’t have one to talk to the odds are you’re not going to do real good either, so the answer is we need at least two, preferably thousands of these things scattered around there as well. And that’s all nice and good, but by the way, if the answer is, if Simon’s system is in Spanish and mine’s in French, it’s really not going to be quite as effective as we’d like to do, so it would be nice to have a standard to go across and talk to each other there. It would be nice to have a mechanism, maybe the internet with some other embellishments on there, as a tool so that we want to talk, not only like on a telephone, we can pick it up and we have a set of wires go across there in a standardized format so our voices actually can do that and now we’re talking, but all this starts to come into place. So electronic health records, the ability to have information exchange in a standardized format are the tools to do it with and standards essentially to allow us to do all those kinds of things.
Now the question is sort of it gets to be an argument, by the way, if you’re going to do all this, who’s the center of the universe? I’m sorry for all of you who are providers in the group here, including Simon and others that have little MD’s after their name, and Rob, is the answer, it’s the person, I’m sorry, the person is the one at the center of the universe. And everything if we’re going to do this right is organized around them, and that means some different things in how we operate. It means that I know we all like to have our own provider organizations and our own provider systems, but we need to think a little bit broader than that part as well. That’s where the personal health record system comes into place because that really becomes one of the tools that they can use to store information, to move information, to share information across there. There’s also service for providing services as well, it is also a tool by the way to have trusted information.
And so if you start to pull all of these little pieces and little dots and things together there, you start to begin to think about how we actually might put this together and actually create a system that is some might speculate might be a virtual health system. We’re not going to get to probably a real one, but we might be able to get to a virtual health system and that’s somewhat what we’re creating here under the EHR’s, PHR’s, information exchange, and standards.
Last slide, so the question is saying well that’s all nice and good but is it going to really happen. And the answer, let me tell you why we think now it is probably going to happen. It’s because there is lots of movement, we talked this morning and this afternoon about the standards part there. VA, DOD, Indian Health Service have bitten the bullet, the federal government has now bitten the bullet under CHI, we’re beyond the discussion of esoterics. As we said at the break here, each new thing about the announcement by Secretary Thompson wasn’t five standards. It was agreement upon standards, it was an agreement upon a process to bring about federalized standards and to lay the groundwork, tipping point being the point, for “national standards.” That’s what was important about announcement. And interesting in the background, by the way, is that it wasn’t just three departments who do health care that were doing it, but by the way, also sitting around those rooms at that time was the Office of Management and Budget. Interesting group to have endorsing this concept and feeling good about it there. You got Connecting for Health as we talked about earlier, we talked about the SDO’s who had spoken here as well, what we were really trying to do is breathe life into those groups and I think we saw a few minutes ago some very serious dialogue that comes from when people believe something’s actually happening. If it’s an esoteric discussion nobody’s too worried about whether they’re going to be in the game or out of the game or whether their stance should be listened to or not listened to, it’s when you actually have on the road to adoption that people start to have serious conversations. This is now a serious conversation.
When you get into the issue of the electronic health record systems there, we’re again seeing movement. DOD’s going to a new system in CACSQ. VA is going to a new system Healthy Vet Vista(?) as its next generation of systems there. Kaiser has bitten some very tough bullets in terms of moving to the Epic system in there as well. Cerner, McKesson, GE, on and on, all those organizations out there are really seriously looking at the next generation of their systems and where they fit in. They’re just hoping they have a willing provider community out there to buy it when the time comes.
That’s another part of the puzzle, how do you prime the provider community to be more involved and more want these systems, not to go for the cheapest system, or sit there and debate endlessly about whether they should have one or not. The answer is get in the game, let’s find a way to do it. They will say by the way, that’s all nice and interesting, but where’s the money going to come from. Well, that’s where you start having discussions with organizations like CMS and the other third party payers out there. Say you know, if you look at some studies like the Blackford Middleton Study and others that there’s a three for one payoff for investing in IT dollars in very sophisticated systems, maybe the time has come to say its any different. And as you are aware of, Secretary Thompson has said some very positive words about electronic health records, Skulley(?) has said some positive words about there, there are even rumors that higher in the White House, a certain individual has said some positive things about that at the AMA, and other things as well.
So the answer is are we on a path to somewhere, the answer is yes. Is it moving toward the end game of 2010? The answer is probably yes. Do we have a shot at getting a major, major part of this done and being majorly paperless by 2010? The answer is probably yes. So the answer is here is what is turning into a really interesting and fun and esoteric discussion in 2001, I would argue today is very hot on the road to a very practical implementation of something which by the way, some of you have been working on probably ten and 20 years longer than I’ve been working on, but the answer is we are actually making this happen.
With that I’ll stop. Thank you.
Agenda Item: Consolidated Health Informatics Initiative Roundtable: Specific Standards - Ms. Adair
MS. ADAIR: Ok, we promised earlier that we would start to share with you some of the preliminary analysis and workings of five of our workgroups, and without further adieu, I talked a little bit about how we formed the teams, so I’m not going to go back over that which is the next slide, but I in fact will just turn it over to Steve Steindel actually if you don’t mind, Steve, to go over the lab result content.
DR. STEINDEL: Thank you, Jared. I’d like to talk to you about the preliminary results of the laboratory result content team. As Jared mentioned, the first step is forming the team, and this was a very good team that was put together, I chaired the team. We had representation from the National Institutes of Health, National Cancer Institute, and Anatomical Pathologist Board in an AP and CP. We had a representative from VA, a pathologist boarded in clinical pathology and an expert in microbiology. We had two clinical laboratorians from the DOD and we also had a representative from the USDA who runs one of their regional labs in California, so I thought this was a very good subject matter expert group in the area of laboratory results. Everybody is a practicing, or was a practicing laboratorian. For those who aren’t aware, I am board certified and have a clinical laboratory director license from the state of Georgia, so I did have another life at one time.
One thing that the first step we need to do is define the scope of our domain. As we looked at this domain one thing that became evident to us was that laboratory result values encompass both a human and a non-human domain, and that if we talked about laboratory result values that we did have to at least mention the non-human domain. We are not obviously going to make very strong recommendations in that area because CHI is focused more on human health care, but the agencies of the federal government in particular, USDA in the veterinary area, FDA in the food, and USDA in the food area, and EPA in the environmental area, and DOD which handles many types of different non-human substances, all voiced opinions to this group that they wanted us to at least note that the non-human area exists.
The next thing that we defined was what constitutes a laboratory result, and while that seemed very simple we found that it was not a simple thing to describe. The first thing that comes to everybody’s mind immediately is the result itself, the value. We actually decided that the result itself had at least four different components or types. One was a number, the actual number that was associated, like with the serum sodium level, and that of course needs no terminology. But a laboratory result is also ordinal, those doing urinalysis we see plus one, plus two, etc., and while that needs no terminology it led to the comments that we made describing this area that I’ll mention in a moment concerning testing methods. Then there was the comparison to cut-off values, which is used a lot in microbiology plus minus, yes no, etc., those types of values. Again, those need no terminology. And finally there was an alphanumeric result or a descriptive result that occurs in things like describing microbiology results, anatomical pathology reports, many types of hematology results, amino hematology, and this description goes on. Those obviously require some type of terminology, and I think that’s what people mostly focus on when they think about laboratory result content and terminology.
But going on into the laboratory result itself we found that we need to include in the report, though this does not have to do with terminology, it does have to do with laboratory results, a strong emphasis on including reference or normal ranges where they’re appropriate. We found that part of this domain was units, that a laboratory result that requires a unit, that does not have a unit is an incomplete laboratory result. Those three items are usually things thought of as encompassing with the laboratory result, and indeed are defined by things like the CLEA(?) regulations as part of the laboratory result.
We went on, though, to say that there were other things that are common in laboratory results and if we wanted to have standardization we should start looking in those areas. One is abbreviations. Abbreviations in medicine are extremely common and they’re extremely common in laboratory medicine, and without having a standard set of abbreviations achieving semantic interoperability is difficult.
The next are we noted was comments. While a lot of laboratory results have comments, like p-mic(?) or hemalized(?) or something like that, those are relatively simple. There are other laboratory results in esoteric testing areas that have very large descriptive comments that are sometimes, that could use some standardization. A classic comment that I have from CDC that has looked into this area is one laboratory in reporting their results has been known to put the comment “some gonorrhea seen”, and I have absolutely no idea what that means.
Finally, we said that to understand the laboratory result you really need to know what the real testing method was, not just a brief description of the testing method, and this becomes very important. Today we’re working in the area of PCR testing, it’s very important to know what the primers were used in the PCR testing and you only know that if you know what the method is. Even in urinalysis it’s important to know what urinalysis method was being used in case you want to compare a one plus result from one laboratory to another laboratory. Generally the manufacturers try to keep those pretty equivalent but there may be differences.
With that introduction, that is how we defined the domain that we started to look at.
We looked at candidates for these domains. Now if you’ll remember for values we only had alphanumeric descriptive values, were the only ones that we needed to find a terminology, we looked at the available terminologies that we could find, we found that MSH, the Medical Subject Headings was a good overall terminology that describes a lot of the domain at a very top level, and could be used in that area at the top level. We then went on and saw that there was another terminology for living organisms used by the National Cancer Institute, the NCBI taxonomy, that was extremely detailed and could be used for research purposes. But in our overall look of things the terminology that we’re proposing, and we will discuss in the report as our leading candidate, looks like SNOMED CT, that sort of cuts between the two that I’ve just mentioned. A good example there is when we can compare that to the NCBI taxonomy, the NCBI taxonomy has approximately 100,000 organisms listed in it, the SNOMED has about 17,000, so I think you can see the sense of description between the two. But we’re working on the report and we’ll submit it to Council and we’ll see what happens, and we’re looking for comments from this group if there’s any others that we should be considering.
In the other areas that we looked at for units, we found that there are several terminologies that already exist in units. They looked fairly complete and we’ll probably be recommending one of them from HL7 which is derived from an ISO code set as a leading contender in that area.
Abbreviations, comments, and testing methods, I’m going to defer for a moment, when I talk about issues and suggestions which I’m moving into right now. The research area may require harmonized specialty terminologies that we could not find. The NCBI taxonomy for organisms was one research terminology that we could find but for describing results in this area terminologies may need to be developed. The non-human area needs considerable work. We found that there needs to be a great deal of improvement in veterinary content, it’s missing, it hasn’t been well focused, there needs to be a harmonization of an FDA and USDA food terminology, both of those have terminologies that describe foods, they’re different. We need to incorporate what’s being done by the EPA and DOD into for the environment specimens and other specimens.
We then found that there were no established terminologies for abbreviations. There are some start a lists that might exist and we propose that that, we’re probably going to propose that those go on to SDO’s to be developed. Comments. We found nobody has worked in the area of comments, it’s a wide open area.
And finally in the area of testing methods, we’re not sure what to recommend there. A good starting point is probably going to be the FDA medical device list, because they certify all medical devices that are being used, including laboratory tests, and they may have a good taxonomy that could be used. If they don’t then I think they should work with people to develop a good taxonomy.
And this concludes the preliminary thoughts of the laboratory result content working group that we’re putting together in a report and will be presenting to the CHI Council. And Jared, are we going to take comments from the group after each one?
MS. ADAIR: We’re running a little short of time so I’m trying to manage so that we get everybody have an opportunity, so if it’s completely appalling to all if we could move to the next one. Simon is that?
DR. COHN: I was actually just sort of curious if anybody had, obviously it’s hard without a written report to work through it sounds like 20 different elements and all of this, I presume you probably would be requesting written responses.
MS. ADAIR: I have no idea who they’d send it to but that works for us.
DR. COHN: Certainly, if anyone in the audience or on the internet has a comment or otherwise about lab result contents you can send them to NCVHS and we’ll be happy to forward them on.
MS. ADAIR: Ok, we’re going to move along now I guess to medication, Steve Brown.
DR. BROWN: I’m Steve Brown with the Department of Veterans Affairs and I’m leading the group on looking at medications. We followed a similar process but are not quite as far along as laboratory results, but overall we’ve set about setting scope initially, doing an initial analysis, refining our scope based on an initial analysis. Then on that smaller set of areas related to medications we’re in the midst of performing detailed analyses and generating recommendations. We’ve had input from a fair number of government agencies including CDC and VA and DOD and LLM, if I’ve forgotten anyone I’m in trouble now.
Initially what we set out to do given the task of medications and adverse events it indicated that there’s a sort of it’s time to cast the net widely. So we started with some of the usual suspects, active ingredients, clinical drugs, dosage forms, packaged products, and the things that everyone would think of regarding medications. But also given the sort of needs of some of the group members we also looked a little beyond the actual product toward chemical kinds of things, to include items such as drug classes or prescriptions, adverse events, label section, actually labeling section headers I should say, indications, contraindications, and just a very broad array of things related to medications in our initial analysis. There’s several more that I won’t get into. And what that ended up leading us towards was that there are a number of things that were just going to have to declare out of scope to get anything done, and also that overlapped significantly with other areas. For example, indications and adverse events all overlap with problems and diagnoses, so and require an information model, so we are not going to come to any conclusions as they specifically relate to medications without trying to ensure that that’s in harmony with other areas where we’re talking about the same stuff.
So after a brief passthrough we decided to take a more detailed look at active ingredients, the idea of a clinical drug which some of you may be familiar with, dosage forms, products and packaged products, a small set of subpopulations relevant to FDA’s needs, drug classes, and section headers for labeling.
I’ll mention quickly some of the candidates, not an inclusive list, to give you an idea of where we’ve been looking. For active ingredients we’ve looked at U.S. adopted names, CAS(?) numbers, chemical names as specified by IUPAC(?), other international approved names such as British approved names, Japanese approved names, international non-proprietary names. We’re looking at mole(?) files that FDA is working to produce and codes associated with those.
Regarding clinical drugs we’ve looked at VA product names, RX NORM names, and products of some of the commercial vendors including FTV(?), Micromedix(?), and Medispan(?), excuse me.
In terms of dosage forms there’s three that we’re looking at fairly seriously, one is HL7, the second is a CDER, Center for Drug Evaluation Research Data Standards Manual, and also there’s listing in approved drug products from the FDA’s orange book.
Getting down to the drug product level, there’s NDC’s, and again in offerings come a variety of knowledge based vendors, folks that I’ve already mentioned, and also drug facts and comparisons.
Special populations, we probably will be keeping that fairly narrow in scope and trying largely to address the needs of the FDA, understanding that that will have to be integrated in with whatever the demographics group comes up with.
Drug classifications, there are a variety of those. I’m personally most familiar with the VA’s but we’re aware of several others, AHFS and USP and a variety of others.
Label section headers, that’s more or less a regulated issue in the United States, so that’s going to be a pretty short list of things to consider. And again for drug packages, that is another regulated item so we’ll be referring primarily to regulations in that area.
That’s a high level overview of how we’ve started with a fairly wide scope, narrowed it down, and named a number of candidates that we’re looking at now, we’re not ready to make any conclusions.
DR. FITZMAURICE: Steve, I wonder was the purpose of developing the medical terminology to be able to describe medications that are commonly prescribed to people and to describe the causes of adverse events? I’m not saying the last right or the way I really mean it but you mentioned adverse events, so how do you apply the terminology to adverse events?
DR. BROWN: As I interpret it it would be for relating bad things that happen to people due to medications, and I think that they are probably grouped together because the lists were, the groupings in the initial listings were limited in numbers and tended to group things together and tried to put like things together.
DR. FITZMAURICE: So are you looking at a terminology for adverse events, or just drugs that may cause adverse events?
DR. BROWN: I think at the end of the day we’ll probably come out with the latter and need to work harder on the former.
DR. MCDONALD: I just want to get clarification on some of the vocabulary about the discussion. I had assumed that medications, well firstly, when you talk about a medical vocabulary, as you know we’re really talking about more than one level, I mean there’s ingredients, and there’s inventory level, and that’s actually one of the beautiful wonders of the complexity of this business, you need more than one. But I guess I’m not clear then, when you’re talking about the different ones you’re looking at, were you looking at them for specific levels or --
DR. BROWN: Yes, it’s level specific.
DR. MCDONALD: Can you make, maybe I didn’t hear it right, but can you make comments about what looks promising?
DR. BROWN: Not at this time.
DR. MCDONALD: Ok, one other question in terms of definitions. One of the handouts had, it mentioned, well I’m confused between the VA version and the other version of the reference terminology for medications that’s out there, I didn’t realize there were two --
DR. BROWN: Well, I can address that as a separate issue, there’s RX NORM which is sort of done, at the cedamidifine(?) 325 mg tablet level what we’re calling a clinical drug with components and active ingredients, and then building upon that is work we’re doing in VA, adding information such as physiologic effect mechanisms of action, and doing it in a formal description logic way.
DR. MCDONALD: What’s the label so I use them right? RX NORM is that what you just said and --
DR. BROWN: RX NORM is the first and NDFRT is the second. I’ll show you that in detail next week.
MS. ADAIR: Ok, thank you very much, Steve. We’re not going to move on to demographics, and despite the fact that I kind of picked on Jorge and said he was doing demographics last time, that’s really not true, I was actually protecting you Beth. Beth, did you want to introduce yourself, she’s been leading off the demographics.
DR. FRANCHEE: I’m Beth Franchee, I work for the Department of Veterans Affairs, and I am the demographics workgroup leader. And I participated with and am participating with several members of this group, including Jorge and Marjorie as well as we had folks from the CDC and CMS and several other individuals involved in this workgroup as well as I think we have Liz Ortizar(?) from the FDA as well.
So with that, we started out with defining our scope and we really had kind of a struggle with how we were going to do that, whether we should start looking at what standards included patient demographics, or whether we should come up with a list of demographics specifically about patients. And in the end we really defined our scope through what is, how we’re delivering patient care and it’s strictly related to patients and patient medical records and clinical care, realizing that HIPAA addresses some of the other demographics per se but not those included for patients.
So to give you a little more verbiage to go with that, we really were trying to set specifics for collecting and storing specific patient demographic data to be used for various purposes, primarily patient care and patient identification. Patient demographic information through research can serve as an important component in identification of health trends within various segments of the population, and by utilizing patient demographic data we can focus on reactions to specific health care regimens and clinical trials. Collected information can be used to track the elimination of health disparities, which is a high priority for several government departments and agencies.
So clearly the crucial domain is patient care including patient identification. Some sub domains that overlap within that domain are financial, billing, legal and regulatory concerns, research and communication. So the standards that we’re currently looking at are HL7 2.4, X-12, and ASTM.
And to provide a little bit of discussion about that, currently X-12 really does not have the robustness for patient demographics that the other two standards do simply because of the focus on either claim data or provider transactions or other processes within HIPAA. Patient demographics has the most gaps that we’ve identified to date, for patient demographics. We came up with about 34 different elements that we believe describe patient demographics. ASTM is fairly robust and some of the gaps within that we’d be interested in some feedback from this group on both ASTM and HL7 2.4, as well as any other comments on X-12. And that is really the crux of our presentation unless Marjorie or Nancy want to add anything to that.
DR. COHN: Clem, and then I’ll have a comment.
DR. MCDONALD: I’m a little off balance, because I thought we were talking about vocabulary, but now it sounds like we’re talking about messages, or which?
DR. FRANCHEE: We really aren’t, we defined patient demographics by the representation of the data elements or concepts that were represented within those standards.
DR. MCDONALD: So when you said you aren’t, you mean you aren’t either of those things? I thought you were starting out with vocabulary but I think you’re doing messaging, and you said you aren’t, so I’m not sure which, what the answer was, whether you aren’t doing either or you’re --
DR. FRANCHEE: Well, Clem, what we did was look at the universe of what was described to represent the concept of patient demographics. What we found was ASTM, X-12, and HL7, now granted HL7 2.4 is certainly used for messaging, but it also represents those concepts very well as I’m sure you are aware, and that is really what we were looking for is to be able to represent those comments, those concepts for patient demographics.
DR. MCDONALD: Let me add one more question, and a further question to clarify. So you wanted to identify the attributes that would constitute, but then did you deal with the codes that would be in those attributes?
DR. FRANCHEE: Yes, in that HL7 represents marital status, and what the selection is within that --
DR. MCDONALD: So you got the codes --
DR. FRANCHEE: Yes, I’m sorry if I didn’t represent that.
MS. ORVIS: As a member of the workgroup, we looked at the vocabularies that were, or code sets that were attached to those, so yes, that’s specifically the question.
DR. COHN: Elizabeth, maybe you can help me on this one, because I’m, once again I think we’re struggling to figure out how to make the best use of time in terms of these conversations. I guess if I talked about interoperability expressed in many different ways depending on what I am doing. I can certainly agree that it may make sense for there to be further robustness and differentiation at great levels of specificity for certain things that may be inherent in other terminologies, but to sort of have well, geez, everything that comes in is a claim in one sort of format and then everything that is done internally in another format, unless it comes in as a claims attachment, in which case it might come in as another format and with these other terminologies, I guess I’m struggling to figure out, once again, I’m just sort of thinking as I talk but is there, don’t you think there’s a problem here?
MR. CHRISTOPHERSON: What you’re raising here is that right now we have a HIPAA version and X-12, and we have this over here. The answer is there needs to be reconciliation, we’re not going to let folks have two different places that you have demographics over here for one purpose and demographics over here for a different purpose. The question is is how to make sure you have demographics that accomplish both purposes. I think that’s the issue of how to get to that point so you don’t have that problem.
DR. FRANCHEE: And that’s really where we’re looking for more input simply because X-12 represents certain concepts but not enough to really represent the patient demographics very well. I don’t know, Marjorie, we struggled with this in the workgroup and --
MS. GREENBERG: Well, I think Beth has described it well but as I said, we went back and looked at esteemed groups such as this one that had defined demographics that you might want to exchange information, and several of the data elements themselves, just the basic data elements aren’t even included in the X-12 standard. And then in some cases where there is a data element the categories are really, the content is not really adequate. So now even in HL7 there’s also some inadequacies but as Clem pointed out HL7 at least has already been adopted as a message standard so that would speak for it I think better than perhaps ASTM which is fairly robust in some of these areas as well. But I think the challenge is going to be, and we’re still discussing this in the Council as Beth and Jared said, is how to get HL7, and this has been the challenge now for several years, to harmonize, where they do have the same data element we need to make them the same. Now it may be, on the other hand, where they don’t have certain elements that maybe they don’t have to have those elements in X-12 because they’re not going to really be used in administrative record. So how you go about that, and I mean harmonization clearly when it’s the same data element you would like harmonization, and that’s going to be one of the things we identify, but whether you need, even though you’re using X-12 for the administrative whether you need data elements that are in HL7 but not in X-12 to be now in X-12 if they don’t have a business case for it, that’s a question I think we’d welcome guidance on.
MS. ADAIR: Right, and I think that that is, I mean this has not come to the CHI Council for any kind of resolution yet, and it was our very distinct purpose of bringing it here today, showing you kind of the things that we have to be thinking about. The benefits to be gained by having it consistent with HIPAA, but we might not be getting the robustness that we feel like we need on a clinical setting. These are some of the challenges that are going to be in front of us as a CHI Council and that we’re going to come to people like you and say whoa, this is kind of like a heads up, they’ve not come, we’re going to come back and have this conversation with you as a Subcommittee again. But these are the types of things we very specifically asked Beth to bring this here today so that you know that we’re not just kind of like saying well, we’re just going to live with the best we’ve got, we might have to, this may be one of those times, I don’t know where we’re going to end up on this one. Is it one of the times when we challenge a group to say geez, what are we going to do? You want to fix? Do we go ahead and say no, we’ll go ahead with two different standards? And this will be one of the challenges in that, ok, there are a lot of people lined up here to talk and I don’t where a watch but I am very cognizant of time and we have two more groups to do and we will come back one more time, and I’m not trying to discourage people from chatting. We brought this to you all today so that you see some of the thought process we’re going through, no recommendations even come to the Council yet, we’re going to have to, we’ll go through this ourselves.
DR. COHN: Ok, briefly Clem and then briefly Wes, and then we’ll move on.
DR. MCDONALD: In this area there may be some things that are special to the federal government that would not apply to the rest of the world the same way. I’m not sure what’s in your set but I know some of the military fields that they’d need in active duty, non-active duty, might be different, that’s number one. Secondly is what’s robust and adequate to one person is overkill and very high cost in another world, and so that, in thinking about the ethnic and racial questions, figuring out if someone is Guamian or not might not be that easy, there’s only 30,000 people or something out of the 360 million, whatever, so the question is is whether one would think about a hierarchy which might use at different levels and different contexts to satisfy and I think that’s probably X-12’s issue, too, is that they, you’ve got to get the patient checked in, we’re not going to be able to do a 20 minute interview. So that’s sort of the tension we should at least expose and be able to see how to deal with it so you could have, the subset would be compatible but you could go in deeper granularity in areas that you wanted to or could or should or had to.
MS. GREENBERG: Can I just to respond to that about the Guamian? Well, the good news is that although neither the X-12 nor HL7 race ethnicity standard is very good, the basic one, we have harmonized on the race ethnicity with an external code set so they’re both the same, and they do have that kind of hierarchy starting with as high as the OMB level down to the very finest level because you might need that.
MR. RISHEL: I just wanted to say that a common business case among HL7 users is carrying enough information about demographics that it can be put into a bill or put into a claim, so if we actually are inadequate in that range I think we’d be very open to proposals to improve that.
DR. COHN: I think it’s Peter from the ASTM.
DR. WAEGMANN: I guess as we have heard it’s more a question of what is the purpose. If you just have messaging of course you want to limit the identification and demographic information, that’s what Clem was saying, you don’t want to have overkill in the messaging part. But if you really want to create a standard for demographics then I would say only for ASTM standard really has the robustness, has all the information in there.
MS. ADAIR: Thank you. I think Steve Steindel is going to do the immunizations --
DR. STEINDEL: No, Jason is next but I’m going it for him.
MS. ADAIR: Jason Goldwater who is at CMS, works, is a happy first time father so he is spending time appropriate where he should and convinced pretty easily actually Mr. Steindel to help him so that he could be home being a dad, I think that Steve was very nice and offered to do this.
DR. STEINDEL: Just a brief report, preliminary report of what’s coming out of immunizations. As was noted Jason Goldwater from CMS chaired this group. They had representatives from CDC’s National Immunization Program, USAID, FDA, and DOD on the workgroup.
And this gets to something that Clem mentioned a little earlier, when this group started to look at their domain they found that it was actually a bi-phasic domain. One phase of the immunizations was messages, and that is really a big area of immunizations, and the other area was terminology. And when they looked at terminology they found that there was this clinical part of the terminology and a product part of the terminology. In the clinical area they had normal descriptive information about immunization, such things as vaccine site, vaccine mode, etc., and then they had the abnormal part of the clinical information in case it was an adverse reaction to an immunization event. And I think we’ve heard that word before, adverse reaction, and I think you’ll see that what I’m going to paraphrase on Jason’s report is that this is still a very open issue that needs to be resolved.
The candidates that they found and that they’re discussing in messaging, they’ve really looked at it and I think while we’re supposed to talk about candidate messaging and everything, for immunization there’s basically in the United States, CDC had proposed in 1992 and has been working with HL7 since then to develop various immunization messages and that’s what’s widely used in the United States, and we believe that that’s what will come in front of Council for the format for the various immunization messaging.
For terminology they are looking for the clinical, the normal descriptive terminologies, they’re considering SNOMED CT, the various HL7 code sets for describing things like site and MEDSIN(?) and haven’t reached any conclusions yet, it’s an open discussion issue with no leading candidates coming to fore. And for adverse events they’re looking also at SNOMED and MEDRA and some discussions between those to as to whether or not to come forward with.
For vaccine product information, again, they’re probably only going to come forward with one recommendation because in this country CDC maintains a vaccine product list and that will probably come forward as the recommendation in that area.
The issues and suggestions for this domain, in the area of messaging, as I mentioned they see that the CDC proposed HL7 message is widely used and do not, well, it’s widely used by a lot of people, we have not really identified how much of it is really message, but a lot of groups do use it, so it will probably come forward as the message structure. But they said that they may need some type of support and information for adverse event reporting messaging, and this is very similar to what we heard from Steve Brown from the medication area.
In the area of terminology, they want to look at whether the widespread use of MEDRA for non-regulatory purposes, it’s widely used for regulatory purposes but it’s not widely used for non-regulatory purposes and needs some comments and feedback in that area. And we’ll probably coalesce with what other recommendations come from the various CHI teams that are looking at adverse event reporting as the way we should handle this information.
For vaccine product information, again, I mentioned the CDC codes, however they do point out that the CDC codes, and CDC is in agreement with this, needs modernization and we’ll probably make that recommendation to CDC.
So this is the directions that we’re leaning on the immunizations, and I think the two significant things that I’d like to point out in this is as Clem mentioned earlier he said he thought these reports involved terminology and as we get into the domains we do see that sometimes they intermix with messaging, and we do have to make recommendations in that area as well. And the second is that this is the second domain that we’ve seen that overlaps with the previous domain in adverse event reporting and CHI Council is going to have to figure out how to resolve these domain specific issues and probably come back to a group like NCVHS with some questions asking for recommendations in this area.
Thank you.
MS. ADAIR: I think the CHI Council just go another assignment, is that I heard? Delegating.
DR. FERRER: Steve go another assignment.
DR. STEINDEL: No, I don’t deal with adverse --
MS. ADAIR: Let’s move on, Jorge Ferrer from CMS led the group on interventions and procedures.
DR. FERRER: Thank you, Jared. I want to give a sort of a very brief overview of where the Consolidated Health Informatics procedures and interventions workgroup is right now today with our current thinking. Initially it was a really difficult task because when evaluating code sets, terminologies, and vocabularies, there’s a lot of work historically that has been done at the code set level and there’s some work that has been done at the clinical terminology level with regards to procedures and interventions, but you really need to ask as it was brought up by Dr. McDonald and a number of folks here, is this sort of in support of a clinical or electronic health record to date, and if the answer is yes then there’s some criteria that have to be evaluated that certainly would not be supportive of just a code set for billing purposes. So from a scope standpoint the clinical terminolgoies, at the group felt should be standard with respect to what the informatics world would recognize as technical criteria such as concept orientation, concept permanence, non-ambiguity, and the other classical technical requirements that are reviewed in the literature.
A clinical terminology should enable clinical users to invoke a set of control terms that correspond to formal concepts organized by a classification schema. This is obviously a radically different perspective, if you’re just actually just evaluating procedure and intervention just to pay bills and since we weren’t we were looking at this from a very clinically driven standpoint, we did exclude existing code sets used for the administrative, financial or regulatory functions such as ICD-9, CM, CPT-4 and HCPCS. These code sets are not intended nor designed for the primary recommendation of clinical care, these code sets do not represent clinical data at the appropriate level of extraction to be useful for decision support by surveillance clinical research purposes or electronic health records.
So with that in mind sort of the next question was what work has been generated to date that begins to look from a clinical perspective at the clinical terminologies for support of electronic health record, and this is some of the work that Dr. Sajansky had done on behalf of NCVHS with regards to narrowing down the potential candidates, and this analysis, and we’re keenly aware that the analysis Dr. Sajansky presented here at NCVHS is still an ongoing work, there’s still a lot of continued analysis I think that needs to happen, but nevertheless at least we were able to narrow down to the MEDSIN and the SNOMED CT as a clinical terminology that we could view from a procedures intervention standpoint.
So that’s basically where the group is to date. It was important, and I think that even though it’s been brought up a number of times today that we have a real sort of understanding as to where we’re going because it’s just a matter of scale. If you just want a clinical data capture for the billing of aggregating or adjudicating a claim that’s one thing, but if you’re actually talking about clinical document capture to support clinical care and outcomes based analysis then the level of depth that’s required to do that is obviously, it’s a magnitude higher. So my question I guess to the group is just to borrow a little bit of the train analogy that Jared shared with us are we on track, and if so is the train moving at the appropriate speed.
That’s all we have to say today. Thank you.
MS. ADAIR: Those are the reports that, I mean you’ve gotten some information that potentially the CHI Council has not even taken a look at yet, but we wanted to share with you kind of what the workgroups are doing, I do want to thank the workgroup chairs, leads for coming and doing this today, thank you, they’re doing great work. But you begin to some of the challenges that we as a CHI Council have and there are the issues about harmonization, harmonization not only within CHI but with HIPAA, we have different drivers, you have administrative needs, we have clinical needs, how difficult is that, you need to think about geez, does it have to be the same if we’re doing it for different purposes, is table look up within a system adequate, I mean these are all the kinds of things that we as a Council and these workgroup chairs will come back and make their presentations that we will be slogging through. If you have any information that you would like to share with us even on these preliminary we’ll be happy to take that into account at the same time, but do know that we’ll be back and have additional conversation or conversations with you on this.
I think that is about it for me.
DR. COHN: I’m looking back to see if there are any other comments or questions from everyone. Obviously, Jared --
DR. BICKFORD: Dr. Carol Bickford, American Nurses Association. I have a question and that’s in relation to the care provider engaged in these activities. Are they incorporated in the demographics discussion and is there a linkage to the interventions and procedures piece?
MS. WARK: This is Cynthia Wark, and there’s work ongoing in, particular in the clinical encounters area. It is one of the six teams that is deployed now and part of the reason that you haven’t heard from that group today is that the timeline for them has been adjusted to account for the fact that there are some variables that might be considered necessary for capturing other information during a clinical encounter. And so addressing specifically your question about providers and going back to the earlier comment about signatures, these are some of the areas that will most likely be cross cutting as the clinical encounters domain is cross cutting, and until we understand better the needs of each of the clinical domains that fit into the umbrella of an encounter, we’ve asked the encounter group to sort of slow down a bit and wait for some of the other areas to come in so that they can reassess encounters in the context of the other clinical domains. So I know that doesn’t really give you a finite answer but it’s sort of a general answer to how we deal with those kind of cross cutting types of information needs.
DR. COHN: Jared and Gary, I really appreciate your coming here and sort of sharing this information with us. This last bit has just sort of reminded me that for input to be helpful to you we obviously need to think a little bit about how we structure the information being shared with the Committee. I’m reminded by the earlier conversations that obviously as much information as we can give before a session that’s possible I think will probably result in more informed comments, and we’re just going to have to think about how best to do that.
MS. ADAIR: Fair enough.
DR. COHN: And I’m sure we will have many more occasions to work on this.
MS. ADAIR: And I think we need to differentiate between when we come as we did today, that the workgroups are giving preliminary information that they’ve not necessarily shared with the Council yet but wanted to do so, we could just surprise you, versus I think that we would come up with a format of information that we can share from the CHI Council once we have kind of gone through our deliberations and then share it with you so that you have something much more specific to react to because we’ve reacted to it, so I think that’s a very fair comment.
DR. COHN: Well I suspect that this will be an ongoing issue on the agenda, I think we’re, I understand our next full Committee meeting is in August and I’m sure that we’ll, I’m sorry, next full Subcommittee meeting is in August and I’m sure we’ll be discussing it, and I’m sure we’ll also be talking about it, is it on the agenda for the full Committee meeting in June?
MS. GREENBERG: I think Jared is providing an update I think at the full Committee meeting?
MS. ADAIR: Oh I am? I’m sure it’s on my calendar.
DR. MCDONALD: I’d just like to comment on all these presentations because going in I was confused and maybe a little bit flummoxed about the categories and how they fit and what you’re really doing but I have to say after understanding what’s in there it looks like really good work and I hope you continue to come up with, it looks like you’ll be coming up with some solid answers and something people can use.
MS. ADAIR: The groups are doing wonderful work, thank you for recognizing that.
DR. COHN: And I suspect it’s going to be relatively painful slogging in many of these areas, especially by the end of the year.
MR. CHRISTOPHERSON: Just so Simon you don’t get the sense, by the way you can view this from afar, you all are invited to -- on the slogging that’s going to be occurring in the days ahead, if this is going to work. I think your point about coming back is that the issue is we do expect us to be an ongoing and frequent visiting prospect here because as Jared has said earlier we have some timetables we’re living with that are fairly acute and NCVHS is going to be route to help us get there.
DR. COHN: Any final comments? Well we really want to thank you, we might actually be adjourning early. Ok, tomorrow we start at 9:00 a.m. and we’re working on PMRI terminologies. Thank you.
[Whereupon, the meeting was recessed at 4:42 p.m., to reconvene the following day, Wednesday, May 21, 2003, at 9:00 a.m.]