[This Transcript is Unedited]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
SUBCOMMITTEE ON STANDARDS AND SECURITY
Thursday, June 17, 2004
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington , DC
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax , VA 22030
P R O C E E D I N G S [8:15 a.m.]
Agenda Item: Introduction – Dr. Cohn
DR. COHN: Okay, why don’t we get started, let me just do a short introduction and then we’ll do introductions around the table and hopefully by that time we’ll have copies of this excel spreadsheet to look at. I think as you know this is intended to be a short meeting, hopefully about an hour and a half in length at this point, especially since we’re starting around 8:15, of the Subcommittee on Standards and Security of the NCVHS. I’m Simon Cohn, chairman and national director of health information policy for Kaiser Permanente. I believe today we’re being recorded but we’re not on the internet, is that correct? Okay, good, and we obviously have a couple of people calling in, Stan Huff and hopefully Margaret Montiakan(?).
The focus today is really talking a little bit about where we are with the e-prescribing work plan, I’ve actually asked, Margaret are you on the line too now?
DR. MONTIAKAN: Yeah.
DR. COHN: Okay, I’ve asked for there to be copies made of the excel spreadsheet that Margaret I’m hoping that you’re going to walk us through. But obviously with an hour and a half you can’t get a lot of work done but it does give us a chance at least to look at what we have and then reflect a little bit about the hearing dates coming up.
Now with that why don’t we just do introductions around the room and then we’ll review first of all our hearing dates between now and our next full meeting and other items and then we’ll move into hopefully that excel spreadsheet discussion. So Maria, would you like to introduce yourself? And of course also if you have to indicate anything you have to recuse yourself for please so do during the introductions. Maria.
MS. FRIEDMAN: Maria Friedman, Centers for Medicare and Medicaid Services and lead staff to the subcommittee.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, staff to the subcommittee and liaison to the national committee.
MS. PICKETT: Donna Pickett, National Center for Health Statistics, Centers for Disease Control and Prevention and staff to the subcommittee.
DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of the subcommittee and I don’t know of any conflicts I have today.
MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina, member of the subcommittee and no conflicts.
MS. TRUDEL: Karen Trudel, CMS, staff to the subcommittee.
MR. VIGILANTE: Kevin Vigilante, Booz-Allen & Hamilton, this is my first subcommittee meeting, I’m not aware of any conflicts.
DR. NELSON: Stuart Nelson, National Collaborative Medicine. I assume I’m acting as staff to the subcommittee today.
DR. COHN: That’s good, that’s good.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the subcommittee and liaison to the full committee.
MR. BLAIR: Jeff Blair, vice chair of the subcommittee.
DR. COHN: Those around the room.
MS. GODGEN(?): Paul Godgen, I’m —
MR. RILEY(?): Bill Riley —
MR. DECARLO(?: Michael Decarlo with Blue Cross/Blue Shield Association.
DR. COHN: Good morning everyone. As I say I’m just going to start out with a couple of housekeeping items and then I’ll ask Jeff and Margaret to sort of talk a little bit about our views of the last set of hearings —
DR. HUFF: Do you want us on the phone —
DR. COHN: I’m sorry, I apologize, it’s early, Stan please.
DR. HUFF: It’s really early out here. This is Stan Huff with Intermountain Health Care and I’m in Salt Lake City, Utah —
MR. BLAIR: At 6:00.
DR. HUFF: Or a little after, and if we talked about HL7 or LOINC or ICD-10-PCS then I would need to recuse myself.
DR. COHN: Thank you, Stan. And Margaret would you like to introduce yourself?
DR. MONTIAKAN: I’m Margaret Montiakan and I’m sitting on the mighty Mississippi in St. Paul, Minnesota today.
DR. COHN: Anyone else on the call? Well first of all I want to compliment both Maria and Jeff I think for really an excellent last set of hearings, I know you’ll be I think reflecting on them a little bit as we move in but I really think it turned out to be a very useful three days and obviously we have a lot more work to do but at least it gives us some foundation.
Now as you know, and once again I don’t know whether or not we will make all of the dates that we have sort of planned but we have, and I think you’re all aware opened up hearing dates for both July and August and next subcommittee meeting dates start on July 28th and go through July 30th, and I think we’re hoping to adjourn by I think mid-day on the 30th, and so that would be three days of hearings or two and a half days of hearings as we often do. And then in August we are having yet another three days of hearings starting on the 17th and adjourning once again, I think I had promised everyone by 12:30 on the 19th we would be adjourning.
Now we have cancelled our September hearings though as some will note, what we’ve done is sort of laterally deposed dates in September which were September 22nd and 23rd, and these made them available to the Privacy Subcommittee thinking that they may want to take some leadership around the security final rule knowing that we’re only about six, seven, I guess we’re about eight months away in September from implementation. So I think most of us think it’s probably time for the full committee to take another look at where we are with the security final rule. So that’s likely to be happening in September but once again being led by the Privacy Subcommittee.
Any questions about that so far? I mean I’m, and Jeff I don’t know, did you want to talk a little bit about the work plan? I guess what I would say is I think our intent is to try to drive to some sort of at least interim initial thoughts, something that would be helpful to the Secretary in the September timeframe.
Now as I say that I’m concerned, I was especially concerned looking at the excel spreadsheet about whether we would really be able to, what we’d be able to say by September but I think really the intent is to try to at least give the Secretary some first notice of our thinking and what we’re hearing at that time with depending on what we have there either we’ll come up with something more polished in November as another part one recommendation but definitely I think the focus right now is to try to drive towards sort of final complete, completion of the project for the May NCVHS meeting, I’m sorry, March. I’m in some different time zone, I apologize. But hopefully for the March NCVHS meeting, which would certainly be, give the Secretary time, at least for the second set of recommendations.
Now Jeff I think I probably have slaughtered your work plan, did you want to comment about the work plan at all?
Agenda Item: Follow-up On May 25-27, 2004 Hearings on e-Prescribing: Refinement of Subcommittee’s Work Plan
MR. BLAIR: Let me try to help you folks kind of zero in on what’s going on with the work plan and that is that we really tried to see whatever we could do to try to accelerate the recommendations yet still have them be some degree of being meaningful. So we looked at, in one of our gating factors is the full committee meeting because that winds up approving whatever we pass on so if we move it up earlier then it had been in November for the interim recommendations to September, become September 1st and 2nd, and that makes our next few months very, very aggressive. And so I really want everybody to look very carefully at the work plan and look at all of those pieces there because it’s pretty demanding on all of us.
The final recommendations would be March 3rd and 4th I believe it is and in order to achieve that we basically have to complete all of the testimony from all of the users and other stakeholders in July and then have that information organized which Margaret will help us with so that we can pass that very quickly to the SDOs and the terminology developers to get them to comment on the gaps and the issues. Now the way we’re zeroing in on this is that, and I had a chance to have a conversation last night at dinner with John, John Lumpkin, and he asked me to take the time to explain this so that people understood.
We pretty well know what the major messages are and what the major terminologies already are just from the first hearings. That’s what people are using today and recognizing those doesn’t give us a whole lot of value because people are doing that today and they’re winding up building more networks today. The added value that we would add is to take a look at where the gaps are and where the issues are, both in May and in these July hearings, review them with the SDOs to say what can you address in terms of those gaps and those issues within a nine or 12 month period to be able to fix the gaps. I think many of you probably saw Margaret’s document, the spreadsheet, there’s a lot of gaps, there’s a lot of issues —
DR. COHN: And hopefully we’ll get copies of it, be brought down.
MR. BLAIR: And we can’t address them all, but between now and September, especially now and August, that meeting, we want to focus in on what are the ones, the low hanging fruit of the gaps and the issues that can be addressed quickly by NCPDP, by the National Library of Medicine, by other relevant SDOs and terminology developers so that at least when the demonstration projects begin in January, January of 2006, it will be a demonstration project that moves the ball forward.
So in order to do that by the way one of the things that we’ve never done before, we’ve always wound up having time to have three drafts of our recommendation letters before we get to the full committee, and what you probably will see when you look carefully at the work plan is that Margaret and Maria will be helping us to try to work in parallel as much as possible, getting our information organized as well as we can, identifying the issues, identifying the gaps, organizing that recommendation letter so that when we get to that August 19th date that we should have a lot of that stuff pretty well lined up so that hopefully even though we won’t have as many iterations of that recommendation letter as we typically do, if we’re well organized and we’ve built a consensus with some conference calls prior to the July meeting and prior to the August meeting hopefully we will have consensus and we could come up with that recommendation letter in a shorter period of time then we’ve been able to do in the past.
Maria, did you have any other comments that you wanted to make?
MS. FRIEDMAN: Not on the timeline, I have a couple comments actually on the substance now that I’m working trying to do the agendas. And I believe it’s in August, July or August we had talked about having other stakeholders in, like chiropractors and alternative medicine people and all of that and I’m having some concerns about that because for one thing the infusion therapists, infusion therapy and some other coverage issues like that are still under internal discussion in CMS. We’re not sure where, how that all shakes out or is going to work together with implementing part D, and of course Medicare doesn’t cover aromatherapy or a lot of alternative medicine and so the question that I have is would our time be better spent on having some other stakeholders come in, we’ve heard during the testimony, and I’ve had a bunch of calls from people who said why don’t you have some actual practicing docs come in, because that’s one of the gaps that we have heard is that the actual users at the very granular office level have issues. Some are doing well and some aren’t and so I’ve had some suggestions about inviting folks like that in.
MR. BLAIR: Maybe one of the options is the written testimony has been extremely helpful to us in May and if we don’t have time to everybody on the schedule for oral testimony we could at least ask them to submit the written testimony. Would that work, Maria?
MS. FRIEDMAN: Not entirely and maybe Karen can help me with this a little bit on chiming in, I’m not sure what value added having the chiropractors and some of these other folks —
DR. COHN: I’m sort of confused here because there’s two different classes, I mean chiropractors I believe in many states are licensed to prescribe medication and so I don’t know that I would throw chiropractors with infusion therapists, I mean there’s another type of provider that can prescribe medications just like any of us who are licensed and otherwise around the table. But it sounds like you’re sort of lumping that along with some other groups.
MS. FRIEDMAN: That’s how the work plan calls for it, they’re all lumped together, and that’s what was giving me some concerns as I was trying to work the agendas. Because we don’t have a whole lot of time and we really need to get the biggest bang for the buck from every single person who testifies.
DR. STEINDEL: Simon, I have, it’s somewhat in line with what Maria was just saying and somewhat in line with what Jeff was talking about. I have a fundamental question about whether our job at this stage is identifying standards or addressing standards. I don’t think that we should be, we’re running on an accelerated timeframe, if we had a good timeframe then I can see addressing standards and recommending to the Secretary suggested solutions, but our job is to identify standards and gaps and not necessarily to address the solutions. And I think the initial report letter should be focused on Dear Secretary, this is what we have identified as standards in areas where standards are needed, where standards exist. And Mr. Secretary here are where the gaps are and we’re going to look at these gaps over the next N months in more leisurely pace.
MR. BLAIR: If I could modify that slightly, what we hope to do is especially on August the 17th and 18th when we review the gaps with the SDOs and the terminology developers, we’re going to specifically be asking them which of these gaps can you address within the next 12 months to be ready by —
DR. STEINDEL: I think the answer to that is going to be sure, no problem.
MR. BLAIR: So we know we won’t get all of them but there may be a few of them that are —
DR. STEINDEL: We all work with the SDOs, they’re going to come up and be very, very helpful. Now whether they can address them or not I think is a different question. Some of the issues that we have in e-prescribing I think anybody that comes in front of us and says yes, we can address it, and this is in the decision support area, the industry doesn’t know how they’re going to implement decision support in general —
MR. BLAIR: That probably can’t be done in 12 months but there might be things like identifiers that might.
DR. COHN: Maybe we should reframe the discussion a little bit only because I think part of the question is is how far we can reasonably get and I think that in some ways I agree with what both of you were saying, that we need to start out by saying the obvious or stating the obvious as soon as we can figure out what that is. And as you know based on our history and the work that you’ve done sometimes the obvious is not so easy to ascertain. But once we have the obvious then the question is what sort of gaps are there and then from there the next question is well, how do we go about filling them. And the question of course in all of that is what will we be comfortable seeing by September, what might we be comfortable seeing by November, what might we be comfortable seeing about by next March. And as much as I would like to say that in September we will have all of this phase one wrapped up, my quick look at the excel spreadsheet led me to believe that maybe things were a little more complex then that.
DR. STEINDEL: Simon, my minor modification is I think we even ought to think post March. Maria just made a very good point, Part D of Medicare Modernization Act addressed the Medicare program and there are a lot of people involved with alternative medicine that really aren’t part of that plan, but the NCVHS might want to look at the question of alternative medicine and how it fits in in e-prescribing but it wouldn’t be part of this particular process, it would be a separate issue.
MS. FRIEDMAN: Maybe farther down the road.
DR. STEINDEL: Down the road.
MS. FRIEDMAN: I’m looking right now, I’m just trying to work the agendas and make sure that we address all of the stakeholders that we need, we hear from everybody we need to hear from and we don’t have a lot of time unfortunately. I mean we could have hearings for three days from just one set alone and so I’m just trying to make sure that we do the agendas, that we hear from everybody we need to hear from, that moves the ball down the field but addresses all of the goals and stays pretty much true to the work plan. I think Jeff’s done a wonderful job in identifying all the stakeholders we need to hear from, it’s just this one group that was giving me a little pause and I’m wondering since we’re on such a tight time schedule maybe we would be better off using that time for something else.
MR. BLAIR: Let me suggest this and Maria not only do I think that the two areas of chiropracty and infusion therapy are ones that we’re going to be tight on, I would be surprised if we’re going to be tight on some others as well that we really feel are important for us to hear from, we might have to wind up only hearing from one representative from the stakeholder area rather then three or four or five and so I do think that if we not just have a black and white, a yes and no, but we have a middle ground of written testimony as well, that that gives us an additional option so that even though we can’t hear from everybody if they are willing to respond to the written testimony that can be helpful.
MS. FRIEDMAN: That’s true, I want to make sure that because I’m going to be deviating from the work plan for that one session and I may need a little slush I just wanted to bring this to everybody’s attention.
DR. COHN: Stan, do you have any comments about all of this?
DR. HUFF: Well, I tend to agree that there’s some of those folks that we could hear from later and focus earlier on other people but I do think that well, I guess the only other thought I had is that if we can again, if we can sort of state the obvious in an early draft people who might not have had a chance to give oral testimony would have a chance to respond formally in letters to whatever we could make available to people. I think if people have an idea of what we’re thinking about and they agree or object they can write us in writing and it doesn’t always have to happen necessarily in formal testimony during a meeting.
MS. FRIEDMAN: I’d like to echo what Stan has said because I’ve heard in my travels and talking to a lot of people and doing the agendas that there are people who don’t want to comment now, they’re kind of waiting to see what kind of shakes out and they want to comment after. So to the extent that we will be hearing from a bunch of folks and we will be accepting written testimony as always that’s really great but I just want to let people know that there are a bunch of folks out there who don’t want to be on the agenda now but they do want to comment on what we come up with.
DR. COHN: Jeff?
MR. BLAIR: I was going to say Karen, did you have an observation?
DR. COHN: Everybody okay so far? I just think that the real question is going to be is how far we can get down the ramp and I mean once again I’m a little less, in my own mind a little less certain that we’ll make it quite as far as Jeff thinks we will get in September. I think that if we can’t get to where Steve says on this I don’t think we should have a letter in September and above all we need to make sure we have a high quality product at all steps of all of this, I mean we have a reputation for good recommendations, if we make a recommendation to the Secretary generally the recommendations have been well vetted and I think the Secretary can rely on the fact that there aren’t any surprise new land mines that we haven’t uncovered so we just need to make sure that as far as we get we are comfortable with it as opposed to try to extend too for a September deadline. And as I said we may have a November letter, very likely we’ll have a March letter and we’re just going to have to be a little flexible on that. Steve?
DR. STEINDEL: In line with that to be productive and have a letter for the September meeting given the dates of the August meeting, which is like two weeks before, we need to go into the August meeting with an internal draft. It will have holes in it that we can refine the third day but if we don’t have a skeleton letter going into that meeting I don’t see us producing a draft —
MR. BLAIR: You’re absolutely right and you’ll probably notice if you look at the work plan that there is conference calls before July and conference calls before August, and in both of those we’re going to be refining the working document, the working document is to basically pull together exactly what you’re saying.
MR. REYNOLDS: I think that we’re going to spend some time talking about the spreadsheet here, but I think if you look going forward as we invite people to testify, since we are trying to put some kind of a framework together, the things that they agree on, or they think that we’re on the right track on, if they could just basically check those off at the beginning of their testimony, and then touch on the areas that might need more work in their opinion so that we’re not hearing, somebody may, I’ve been on the other side of your table a number of times and if you could come in and say I agree with one, three, four that you’ve already passed out publicly —
MS. FRIEDMAN: Now I want to focus my comments on seven.
MR. REYNOLDS: That’s correct, so number seven, I don’t think you’ve vetted seven enough, because I think this, we’ve heard from a significant portion of the players, and maybe a little different then Maria’s earlier comment, we did hear from some people who actually are practicing physicians, I know who they were representing but the one lady in particular had tried three or four times, so I think we’ve at least had a preliminary look at some of these people. And this chart it’s obviously now visible and it’s out here and now that it’s going to be shared so this becomes the grid that we’re working for, we either add to it, take a whole line and go that looks like it’s going to play, and it’s just give a better framework, if you have to speed up your time, if we didn’t have a framework and we didn’t have something we were talking about I’d think speeding up the time is just like a fast free for all, but this puts good structure to at least our thinking and if our thinking blows up in our face for some reasons we at least are putting it against a structure.
MR. BLAIR: In a sense if I may say this, okay, because you look at a spreadsheet and the first time you’re going to look at it it’s going to be overwhelming and I think as Stan Huff has indicated, and Maria as well, there’s going to be a certain amount of this where we can wind up saying okay, here’s the first ten, 15, 20 percent that we can identify what needs to be done in the next 12 months and that, and which standards there are terminologies and what might be able to be done, and those are the ones we focus on and all those that are complex or contentious where more time is needed then they get moved to the area for future assessment, and so we do some triage.
DR. COHN: Maria and then Karen.
MS. FRIEDMAN: Some of the stakeholders coming up, people I’ve been having conversations with, have looked at the questions we’ve asked to previous testifiers in the grid and said wait a minute, that doesn’t work for us. And in fact we heard that also from the physician groups who came in who said all of this really nitty gritty stuff is transparent to us, we have kind of different kinds of issues and standards that we are concerned with, for example the state boards of pharmacy, their standards are not some of these nitty gritty things, they’re more global in terms of some of the things we’re interested in like the minimum dataset and some of those issues. And so Jeff and I need to have a conversation about what questions to ask those people that’s a little, it’s related but a little bit different then what we did the last time around because just who they are and where they sit.
DR. COHN: Well, and maybe part of the question is as part of the conversation, part of the invitation, maybe there does need to be some interviewing of these people to identify if these are the right questions and what do they think are additional or different questions that are relevant too.
MS. FRIEDMAN: That’s what I’ve been doing and why the agendas aren’t as far along as I would like them to be at this point.
DR. COHN: And there’s some people will think the questions are right. Karen, you’re next and then Stephen, I’m sorry.
MS. TRUDEL: Just a couple points I wanted to make, one is there is absolutely no question that the department and the Secretary are very interested in doing whatever we can to make sure that e-prescribing becomes a reality well before 2008, and I know that the administrator is very pleased that there will be some preliminary recommendations coming up in September. Even if the recommendations, if some of the recommendations are, there’s a gap, we haven’t identified how to fill it, we may be able to figure out a work around that will work for Part D, for instance with patient identifier. We have a patient identifier for Medicaid, Medicare, so that is less of an issue then when you look at e-prescribing in the larger sense, that issue still remains when you’re talking about a national implementation but is not so significant when you’re talking about rolling out the Part D benefit. So I guess what I’m saying is I would encourage you not to feel that you have to solve all the problems, I think you need to identify the problems, some of the solutions, maybe some of the partners, and include that in the recommendations and then those of us who are actually going to be doing the implementation can take it from there and may be able to add some value to the recommendations to come up with a viable implementation. And the implementation on day one as I think we’ve all talked about isn’t going to have all the bells and whistles that there will finally be and I think that’s pretty well understood too.
MR. BLAIR: Karen, there’s one thing that you indicated to me when we were discussing this in terms of the agenda and the contract and all, anyway, that maybe the rest of the committee doesn’t know that is important and that is that while we want to move things forward the January 2006 beginning of the demonstration project, you were indicating to me that cannot move forward and therefore that means that that window of if we get the recommendations, some preliminary recommendations to you quickly with some things that can be improved that that’s a window for moving the ball forward on standards and the terminologies.
MS. TRUDEL: Let me clarify that a little bit. My point was that there was no Part D benefit prior to 2006 so that if we’re doing pilots in conjunction with Part D those pilots can’t start before the benefit is available. If there are implementations that are, and this point I didn’t make when we talked, if there are implementations that are already out there that we want to assess as part of a pilot there’s nothing that says that we can’t do that. And indeed one of the things that I know CMS is interested in doing is trying to get a better sense of exactly what is going on out there pretty much to get a sense of all of the implementations that might contribute information to a pilot later on.
DR. COHN: Now Steve has a comment and then I’d like to actually let Margaret walk us through the spreadsheet.
DR. STEINDEL: My comment is somewhat in line with what Karen was just saying in looking at the spreadsheet, we need to focus in that the purpose of this is Part D Medicare and e-prescribing in relation to that, which is one population. There are a lot of items in the spreadsheet that we’ve identified as gaps that also fit into the larger picture of the National Health Information Infrastructure, EHRs, etc., and we want to make sure that whatever standards we recommend also fit into that picture as well, so I don’t want to see us rushing on identifying standards that will work for e-prescribing and then all of a sudden they transfer and may not work in the larger picture. So it would be better for us to identify it as a gap, make a note of it, and as Karen has pointed out use a work around to put e-prescribing in effect, like for instance the patient ID, which is a good example, a very good example of what I’m talking about.
DR. FITZMAURICE: So you’re suggesting Steve that we have two scopes, one scope is make Part D work for the Medicare population and secondly keep in mind the National Health Information Infrastructure and note where we need to branch out or solve a problem that the Medicare program may have already solved.
DR. STEINDEL: Our focus is identifying standards for the Medicare Modernization Act, that is what we’re charged with in that act, and I think we need to look at what we’re doing with respect to that goal. And we need to make sure that whatever we’re doing in that goal doesn’t jeopardize with what the NCVHS is looking at as the larger goal.
DR. COHN: Well I think we’re all agreeing with each other so hopefully —
MR. BLAIR: The way David Brailer(?) put it was don’t come up with e-prescribing standards that are another stovepipe, they have to meet the goal and it’s a near term goal, we have to do it as best as we can but we have to keep in mind that it still has to at least at some point be consistent with other standards and terminologies.
DR. STEINDEL: One specific thing is identifiers because that’s a major issue that needs to be discussed.
DR. COHN: Well with that Margaret do you want to walk, are you there Margaret?
DR. MONTIAKAN: I’m here.
DR. COHN: Would you like to walk us through the working document since it seems like everybody is in one way or another referencing it already.
DR. MONTIAKAN: May I ask one question about the work plan? Are you going to include some guiding principles for recommending standards like you did under HIPAA or are you planning using those that were developed for HIPAA? Or is that not necessary in this case?
DR. COHN: Well, that’s a heck of a good question —
MR. BLAIR: Can I answer that a little bit?
DR. COHN: Well you can try and I’m sure Michael may have a comment as the author of the guiding principles.
MR. BLAIR: Margaret in this case when the Medicare Prescription Drug Improvement Modernization Act, the section that addressed e-prescribing standards, they gave a list of the areas of standards that we should be looking at and they gave a list of, they didn’t call them criteria or guiding principles but they said things we should consider such as patient safety, such as cost, and that’s the second table in what we sent out to the testifiers. So while it’s not called guiding principles the law kind of set forth what is very similar —
DR. COHN: And we should let Mike, but I guess I’m sort of thinking that we probably ought to look back at some of the previous guiding principles just because they’re really, they probably are not so different then all of the stuff and it might be a useful piece to throw in. Michael?
DR. FITZMAURICE: I think Simon you’re right, a look back would be good and also intersecting it with the law, the law I think is more restrictive in terms of here’s the job to get done for the Medicare Modernization Act and yet Steve pointed out earlier we have to look and see what the rest of the world is doing. For example on IDs Medicare has a, they know what the length of the ID for the individual but we may want to recommend that be aware that you might want to have longer lengths because we don’t know what’s going to happen in the private sector for unique health identifiers. There may be some voluntary system come up and we want to be compatible at least with what the private sector is likely to come up with and so not restricting ourselves to fixed field lengths for example really would it a lot, we don’t face the Y2K problems with field lengths, something like that. But on the other hand I think most of the principles follow right on to what we’re doing, we want ease of maintenance, we don’t want it tied in to particular technologies. I will look at the guiding principles and I will intersect them with what we have for the Medicare Modernization Act and report back.
DR. COHN: So it sounds like Margaret we have an assignment here, Michael is going to work on that.
DR. MONTIAKAN: Good, the reason I asked was because I want to clarify that the ferchy(?) reflex recommendations from testifiers relating to specific types of standards, and there were also recommendations that the testifiers made with respect to things like implementation and other things like that which I’ve not captured yet which I will, but I felt like those kinds of recommendations related more to guiding principles and selection then, that’s why I brought it up.
DR. COHN: Sure, things like usability for example —
MR. REYNOLDS: Mike, on your timeframe is there any way we could get that before the July 28th hearings so that we could use that plus this kind of as our thinking, putting our thoughts together, as we start hearing further testimony?
DR. FITZMAURICE: Let me say yes and let me qualify, for the past several years we’ve worked through July and August and I’ve been permitted to carry over some leave, I’ve got two and a half months of leave that will go away at the end of this year, and I don’t have two and a half months before the end of the year, so I will get it done, I will work vacation around that and take whatever losses —
MR. REYNOLDS: I was just asking the question, I was not giving an assignment.
DR. FITZMAURICE: Well the answer is yes, I will have it done by July 28th.
DR. COHN: And Michael hopefully the good news is that since you already have, we’re already thinking about is I think your previous guiding principles, the point is I think as Jeff commented that there’s some pieces, things in the legislation like the real time and all of that stuff that we could sort of potentially add to it or modify, one condition not being a gigantic effort, this is not like the first time when you had to come up with the guiding notes the first time —
DR. FITZMAURICE: The first time was a lot of input from a lot of people, it wasn’t me sitting down writing it, it was a lot of input from people around the table as well. What I envision it as looking at the guiding principles for HIPAA, looking at the guiding principles for the PMRI standards and adding to it or looking at the intersection with what MMA calls for.
DR. COHN: Great, great.
DR. FITZMAURICE: And there are probably decisions to be made, I’m not going to come out and say here are the final guiding principles, I’ll say there could be conflicts here, and it may be the committee wants to resolve those conflicts or at least to work them.
DR. COHN: Market, thank you for that question.
DR. MONTIAKAN: And certainly Mike I can help with that because in culling out the other recommendations that are not directly related to a standard they probably will match up with those two sets of principles.
So what we have here in terms of the excel spreadsheet is basically what I did was I took Stan Huff’s framework that he had started working on and I came up with a set of columns and the first eight columns have convoluted them, the last three columns related to the old recommendations and PDAF(?) recommendations and priorities could be built in, nothing expected to be in there yet.
I suggest that the way to review this is to first look at only the first column, types of standards, because I started identifying types of standards and then filling out all the other columns and found that I was constantly coming up with new types of standards that people were referring to or using different terms for the same standard type that already was on my spreadsheet, and so I actually went back and said I’m going to forget about what standards exist or what gaps for the moment and I’m just going to try to get a handle on the types of standards we’re talking about and that was not a totally easy task in some cases. So I thought if I walk you through the first column first then we could kind of go back and walk through the rest of the columns in relationship to that —
DR. COHN: Great idea.
MS. FRIEDMAN: Can I just interject really quickly, the reason it was set up like this is we had had a talk before about how are we going to come up with recommendations given all of the testimony that we’ve heard and all of that so the idea is to have this organized in such a way that we can just add to it and keep it rolling so that we don’t have to do a lot of work come August, or before August, to figure out where we are and where we’ve been.
DR. COHN: Well, I think we also, these are organized in principles to help, I mean there’s been enough testimony at this point that I think if we don’t keep something like this we’re going to forget from meeting to meeting where we’ve even been.
MS. FRIEDMAN: The other thing is that it will just be an even bigger scramble at the back end so the idea is to try to keep a working document to keep us organized and focused as we go forward and I think Margaret has done a great job, so thank you Margaret.
DR. MONTIAKAN: So the first set of standards was identifiers and it seemed that the testifiers identified that providers really had two types of identifiers that were needed, the prescribers themselves, the person, and the location where they were, where really the record was kept and really you would call back to get further information, which would be the clinic, the office, whatever. Then there were the dispensers, which were typically pharmacies but not always pharmacies as we normally think of the corner drug store but the .com’s and other kinds of dispensers. And then there were patients and health plans, although health plan identifier was not mentioned very often in the testimony but of course we know that that’s anticipated under HIPAA. And then one testifier did mention an identifier for PBM so I included it although that again was not something that was commented on very much.
So with respect to the types of standards under identifiers I feel reasonably comfortable that I’ve at least go the categories relatively complete.
DR. COHN: And if we can come up with any others we should send them to you.
DR. MONTIAKAN: Yeah. With respect to messages, however, that was sort of a different story because this was where a lot of people used terms in different ways and also in addition I found that although NCPDP might say these are prescriber initiated or dispenser initiated in reality the messages in some cases were being initiated and in some cases were being received and in other cases they were being requested and received. And to sort that out because I think some of the testimony that was heard, especially from the physician groups, the provider groups, was that in some cases they weren’t receiving messages that they wanted such as an acknowledgement of receipt, but they also were in a position of potentially receiving a message that maybe they didn’t always want, like the fill notice which is different then a receipt acknowledgement. So what I did do for messages was identified the type and then try to indicate whether this was a message that was basically sent, received, or sent and received. However, I did not indicate where it was being sent to or where it was being received from because I felt like that was just yet another level of complication which I could add but also seemed to be fairly apparent from the name of the message itself, you could kind of figure that out.
So I have prescriber messages and clearly there are new prescriptions, change requests, refill requests, cancel requests, and renewal requests, and those are all typically sent by prescribers to pharmacies, to dispensers. There is a return receipt that prescribers would receive once they sent a message which often they don’t get but could. There is the fill status notification that again they would only receive, they wouldn’t request that, they would then receive it when it occurs.
Eligibility and benefits, sometimes these two messages were talked about sort of in the same breadth as if they were the same and in other cases they were discussed as being quite different messages so I did identify them as different. And in this case you would typically find that they, the prescriber would send a request for eligibility or send a request for benefits information and then receive a receipt back.
Formulary notification, that would be the same, prior authorization, and again prior authorization, eligibility, benefits, they aren’t always, they aren’t exactly the same necessarily although sometimes they were used in the same way. Medication history and here under prescriber messages they just put medication history although you could elaborate upon medication history which I did do under health plan. And I just don’t know how much duplication should be included and like from which perspective we’re looking so I tried to make the categories somewhat mutually exclusive but that was hard.
Adverse drug event and allergy reporting, orders sent but not completed, lab results, would be special kinds of cases so I tried to go from the simple to complex in order.
DR. HUFF: I think the one thing I would say is there’s a distinction about the formulary notification, that is there are two major strategies for formulary, one is that you have some way of taking a whole, basically transmitting the whole formulary to somebody or you can ask what’s the formulary that pertains to this particular patient in real time, and those are very different kinds of messages, one is basically a big batch message and the other one is a very specific patient specific message that relates to formulary.
DR. MONTIAKAN: I think those are important distinctions, maybe we could say batch formulary versus real time transaction formulary.
Dr. huff: Yeah, something like that would be helpful I think.
MS. FRIEDMAN: And make that patient specific too.
DR. HUFF: Patient specific transaction or something like that.
DR. STEINDEL: In line with this I think those are two basic formulary messages but I think we should inquire of the industry what they would think of as a set of messages for formulary information. Those are two that came immediately to my mind as well but I don’t know if there’s any others.
DR. COHN: Well, we should ask.
DR. STEINDEL: Yeah, we should ask.
MS. FRIEDMAN: We’ve heard that they’re doing it to a certain extent that they have some work arounds that they’re using.
DR. COHN: I think CD-ROMs in the mail work for some of this.
DR. HUFF: I mean I think this is the way that it should be organized but I think there are important questions to say if these things are happening at the same time can’t I ask about benefits and formulary in a single transaction or in a single exchange instead of having, asking about benefits and then asking about formulary because that’s just going, but anyway, I think it’s still organized correctly but those are questions we can ask when people start testifying further.
MS. FRIEDMAN: And Margaret can certainly put that in the limitations or make a note of it in one of the columns there.
DR. MONTIAKAN: I would hope, this is an aside, I would hope that this discussion and this list of types of standards would help formulate questions for the SDOs.
DR. COHN: And the further testifiers coming forward.
DR. MONTIAKAN: Yeah, right. Okay, so then we have dispenser messages —
MR. BLAIR: By the way, the column that says for SDOs, it’s implicit, that’s for SDOs and terminology developers, any developer of any type of standard.
DR. MONTIAKAN: The column for existing standards?
MR. BLAIR: Yeah, it just says SDOs, but it’s not just messages, it could be NLM, it could be FDA, it could be any of the folks that we’re looking at.
DR. COHN: Jeff, I think you’re going across the column now —
MR. BLAIR: I was just saying that the heading just said SDOs but it’s broader then SDOs.
DR. MONTIAKAN: Okay, under dispenser messages I took the list from the way NCPDP had organized this which was refill/renewal, change request, and under change request, DUR, drug utilization review, formulary, and prior authorization. And then another one was filled notification, dispense cancel request, eligibility, benefits, prior auth, and medication history. Now this list is not exactly mapped out at least in terminology with the prescriber messages, it sort of bothered me, but I sort of felt like we needed NCPDP to kind of help us with this.
DR. STEINDEL: I want to back up to Jeff’s comment, because when I’m looking at the list that Margaret has put together on type of standards I look at these as all messaging standards. I don’t see specific carve outs for code sets or terminology and I think when we’re identifying the message —
MR. BLAIR: If you look down further you’ll find them.
DR. STEINDEL: Even looking further, Jeff, I think in the area of when we’re defining messaging standards we need to identify the code sets that are involved in those standards as a second level.
MS. FRIEDMAN: What about the content though because some of these have content specific standards —
DR. STEINDEL: Both.
MS. FRIEDMAN: — that we’re going to want to include as well.
DR. STEINDEL: Both, yeah. But I mean some of it, like if we have drug name, we want to say what we would like as the code set for drug name, if it has weight you don’t have a code set associated with that.
MR. BLAIR: So what you’re saying is that even if there may be an issue related to terminology code sets or identifiers or content you’re saying the perspective we should have is a message perspective.
DR. STEINDEL: A message perspective.
MS. FRIEDMAN: At least in this section?
MR. BLAIR: A column heading that says SDOs.
DR. MONTIAKAN: Say that again, that last thing?
DR. STEINDEL: When I’m looking at the recommendations, yes there are some specific items in there but most of these came down as messaging standards, format for transmitting information. And we may recommend one messaging standard for a good number of these but I think we need to identify what we want in the way of code sets or where code sets are lacking in the development.
MS. FRIEDMAN: I just don’t want to get the content piece lost because that’s one of the issues with the states, that they require certain pieces of information, it varies from state to state, and that’s also very critical for us.
DR. STEINDEL: That comes when we’re delineating what’s involved in that messaging standard, what the content of that standard should be.
DR. MONTIAKAN: Steve, could I ask you a question? Are you suggesting then that I take the list that I have under terminologies, codes, classifications, and vocabularies, and sort of do a matrix format that I would relate those terminologies to the messages and then also have this under —
DR. STEINDEL: That would be awfully complex.
DR. COHN: Let’s not do that quite yet. I guess what we’re hearing is in terms of thinking about message formats and I’m sort of reminded of the CHI work because obviously there’s a message format, there’s as Maria described the fact that sometimes we’re actually lacking data elements that we need, it’s really the content issue, and then the third piece is filling in, what you fill in those data elements with, which is the code set issue –
DR. STEINDEL: And we would be pointing to the terminology section that she has in there.
DR. COHN: Well, that’s right but remember as we saw with HIPAA, I mean unfortunately we’ve all had a long experience with this when there’s external code sets, there’s internal code sets, I mean the issue is there’s many different ways and we just need to make sure that we’re talking about the important ones and sort of being aware of the others.
DR. STEINDEL: And it sort of sinks in with everything else.
MS. FRIEDMAN: I mean the idea of free text just triggered an example to my mind, I mean one of the biggest issues we’ve heard and the biggest gaps is the last of a standardized sig. and so a lot of people are dealing with that as free text at the moment. And so at some future point you might want to have some kind of standard code for your dosage.
DR. COHN: Let’s hold that thought until we get into this.
DR. STEINDEL: The standards exist just nobody has agreed to them.
DR. FITZMAURICE: What does sig. stand for?
MS. FRIEDMAN: It’s the dosage.
DR. COHN: It’s not the dosage, it’s the instructions —
PARTICIPANT: — on the label, so why is it sig. and not XQY?
DR. NELSON: Because it’s a Latin abbreviation, I’ll look it up and tell you.
DR. COHN: You have the right person for that. Margaret, why don’t you continue?
DR. MONTIAKAN: Okay, so the dispenser messages, again if anybody’s got better ideas or I’m missing something but I do think NCPDP could help us a lot with that.
For health plan and/or PBM messages there’s enrollment and premium payment, eligibility, benefits, prior auth, and then under medication history I tried to define the different kinds of medication history we’re looking for, drug allergy checking, drug allergy results, drug lab testing, drug lab results, duplicate therapy. Under formulary then process, data content, file format, therapeutic classification, and stuff(?) therapy.
DR. HUFF: That’s the part I didn’t understand, Margaret, what does process mean in this case?
DR. MONTIAKAN: I thought I took that from your framework.
DR. HUFF: I’d have to go back and look because it doesn’t, I mean whereas these other things mean, I’ve got a mental image of a message flowing and who it’s flowing from and to, I don’t know what process refers to in terms of a message at all, and I don’t know what data content refers to or file format or —
DR. MONTIAKAN: With respect to formulary.
DR. HUFF: Well, in this section, I mean line 69, I don’t know what line 69, actually I don’t know what line 69 to 73 mean.
DR. MONTIAKAN: The CAQH I think was also a primary source there so let me flesh that out a little bit more —
DR. COHN: So Stan help us, we got preoccupied with a phone that was signing to us. Your concern is on this formulary about how it’s being subdivided? Is that the issue that you were trying to describe here under the health plan and PBM messages?
DR. HUFF: Yeah, I don’t know —
DR. COHN: Is that what you were concerned about?
DR. HUFF: That’s what I was referring to but now it’s starting to —
DR. COHN: I don’t know if it makes any more sense having asked the question.
DR. HUFF: It still doesn’t, I guess I can make data content make sense but I don’t know what a formulary process message would be, or formulary file format message would be, or formulary therapeutic classification or something —
DR. COHN: But having said that you would agree that there is a formulary message something or other that does relate to PBMs —
DR. HUFF: Oh, yeah.
DR. COHN: So we’re talking about that as a sub-content, we’re obviously also interestingly noting that health plans and PBMs, at least some of them were talking about sending down messages related to medication history. And Harry has a question.
MR. REYNOLDS: Since we’re touching on health plans and PBMs again, back on page two, at the bottom of page two where it talked about the actual identifiers for PBMs and health plans —
Margaret back on the bottom of page two we list health plans and PBMs as identifiers, I just happened to pull my card out just purposely to look at this, isn’t there a category we’re missing on here as you think about it which is called the actual network? Because for example there’s the health plan, there’s the network that it goes through, and there is the PBM that it ends up with. And so if you look at most cards you do not see the actual PBM name on it okay so I think we’re missing a category below here that when it all started coming together didn’t, so you could put the name of a PBM but nobody would know how to route it from the doctor through what network to get the information from the PBM and health plan is actually in many cases not even —
DR. COHN: Is the network like the clearinghouse?
MR. REYNOLDS: Ours is paid, which does not —
DR. COHN: Harry, is the network like the clearinghouse? Or is that something different?
MR. REYNOLDS: It can be the network, it’s a pathway. Again, I’m not necessarily, I don’t have the answer, what we need is when you put a PBM down —
DR. MONTIAKAN: Would that be like a switch?
MR. REYNOLDS: It’s a switch, the switch, that’s what it is and so what happens is it’s not a real name of a health plan and it’s not a real name of a PBM —
DR. STEINDEL: Harry, I’m looking at mine and I don’t have anything that resembles a network number, I mean I just have a group number, an ID, the plan ID.
MR. REYNOLDS: No, I understand, but I’m just saying some go through networks, some may not, I don’t know, but the point is if we miss a whole category here of how this works and start setting identifiers —
MS. FRIEDMAN: That’s one of the insidious things about this because a lot of this is transparent to the different entities who are involved in the process.
MR. REYNOLDS: Right, but when we’re setting up a standard and we don’t have an identifier for the network that it would go through —
PARTICIPANT: So the category is the network?
MR. REYNOLDS: I don’t know, again, I’m not the expert —
DR. COHN: Let’s hold that thought and note it.
MR. REYNOLDS: Just make sure we don’t miss something.
DR. COHN: You’ll speak to it in July, okay, so we’ll hold that as a category, Margaret, do you want to continue on noting that, actually we are making progress, we’re on page five of nine and it’s 9:20 so we’re not doing too bad.
DR. FITZMAURICE: Simon, can I ask what does CAQH stand for?
DR. COHN: It was a testifier.
MR. BLAIR: I think they were from Florida —
MS. FRIEDMAN: No, they’re local D.C.
DR. COHN: Margaret, would you like to continue forward?
DR. MONTIAKAN: The next set of messages was drug knowledge base messages and here I identified retool(?) substitution, lower cost drug or therapy alternative, drug/drug interactions including severity, drug/lab interaction, allergy group, and those guidelines weight and age and overdose data.
DR. COHN: Just an odd question, obviously you have some knowledge base messages here and you also have some knowledge messages on health plan and PBMs, the distinctions here make sense, correct?
DR. MONTIAKAN: That’s part of the problem, Simon, I mean obviously all of these messages are going to and from the various groups and so —
DR. COHN: You don’t have to solve it right now, I was just noting that, it was so close to each other —
DR. MONTIAKAN: Yeah, I know.
DR. HUFF: I was going to hold the comment but I mean one of the things that occurred to me is that, I mean the way its been done now is to think about sort of each receiver of the message and put the messages that come in and out, I mean the other way that this could have been done basically is to state the message, and the way we’ve done it now you end up with the same message type showing up in multiple categories, once for the sender, once for receiver, category even of sender and receiver. And I mean the other way could have been to say a message type once and say in a given column sent by this guy, received by this guy, and there might be more then just two participants in that, but then you would have a given message type would only appear once in the sheet and that would reduce the number of rows substantially.
DR. COHN: Stan, you’re almost talking about an information model I think.
DR. MONTIAKAN: And you know Stan I think we sort of started talking about that a little bit and I could actually do that easily and have two views of this, one view might be the one that sort of goes forward but the other view be more of a working document to ensure completeness. The concern that I had was that some of the messages are clearly the capability exists but I think the most striking issues in terms of the acknowledgement of receipt and fill notification were that even though the message exists and could be sent and could be received some people really wanted them and they weren’t getting them and some people didn’t want them and maybe were getting them and I felt that if some of these messages such as the acknowledgement or receipt could get lost if we identified it in just one place.
DR. COHN: You know Margaret I think it’s important for us to see it this way because I think we observed very early on and as I remember in one of our early conversations about the redundancies that occur between, in all of this and I think actually that would be something that would be disguised easily if one got into sort of a higher model sort of approach. This actually is very interesting, useful information because there may be some opportunities for, I’m trying to think whether this falls under administrative simplification or clinical simplification or prescribing simplification, messaging simplification, but I think it does sort of point, begin to point out some of those opportunities.
DR. MONTIAKAN: Yeah and we can always collapse it to a higher level later.
DR. STEINDEL: I actually think when you look at the script Stan itself that it really exists that way, there’s a higher messaging standard and a description of how it can be used for various purposes.
DR. MONTIAKAN: But the other thing I think is important also is that in some cases the prescriber may only have the capability to receive an X-12 message and not the NCPDP message even though the NCPDP message is the one that is normally considered the one to be that particular message. So again you sort of lose the fact that that capability doesn’t exist in a vendor that’s supplying products to the provider.
MS. FRIEDMAN: Isn’t that one of the reasons they’re going to try to do the crosswalk and get that figured out?
DR. COHN: But I think that was HL7 to NCPDP, that doesn’t solve the other, I mean and this is something obviously that we’re all beginning to note that the physician is sort of at the nexus of about seven different standards organizations —
DR. STEINDEL: And doesn’t attend any of the sessions.
MS. FRIEDMAN: Well, it’s transparent to them anyway to a large extent.
DR. COHN: Well, I mean I don’t think it’s an issue for today but I do think it’s an issue for the subcommittee later on as we sort of move through all of this stuff. Things were different a couple of years ago where the physician was largely unaffected by all of these, now suddenly the physician is being effected by all of them and if you were a provider you wouldn’t know where to go because this has gotten so complex and the end point of all of this is the physician and his desktop or his office staff and his desktop —
MS. FRIEDMAN: I don’t think physicians as a group have largely, at least at the practice level, have awakened to this yet but it’s going to hit them soon.
PARTICIPANT: Most of them don’t even know what it means.
DR. STEINDEL: I think to go one step further, most of them don’t want to know what it means. They’re going to want it put on their desktop in a transparent fashion and we’ve heard from people who do provide those types of services.
MR. BLAIR: I think maybe that’s true today but once these standards go into effect and we have electronic prescribing some of them may feel like they’ve lost a certain degree of their authority and decision making and influence and they may not be very happy with it.
DR. COHN: The issue is not the standard itself, it’s more like when you have a new data element that comes down and a new requirement for capture or whatever, which of course at the end of the day are what these standards are all about, and the question is is who impacted all of those decisions.
But once again I don’t want to get, if we don’t watch out, I mean this is an issue that I want the subcommittee to notice and be aware of, we can’t solve this one today and it may be a conversation with all of the SDOs at some point coming down the road.
MR. REYNOLDS: One reason I think this example of the drug knowledge section should be considered to be left separate onto itself and not collapsed too much into everything else is that, back to our earlier discussions, what could Medicare do, what could we recommend, how could this move forward, there’s a difference between giving factual information, strictly factual information to the doctor, and that’s what medication is a person on, basically those kinds of things and the art is still left to the doctor and the decision is still left to the doctor. That philosophically could be step one. Some of these things get into the art and are a little more complicated to do in my opinion especially getting the industry to agree how they consistently would do these drug/drug or these other things based on weight, age, everything else. You start getting into another degree of complication so as we look at letting Medicare move forward in some of our earlier discussion today, these are some of the things that if we roll too much of this in up front it may make this thing a whole lot bigger right out of the chute. I didn’t say there don’t need to be standards and I didn’t say you needed to go forward with it —
DR. COHN: And I would describe this a little differently, I would call this the science of medicine as opposed to the art, as opposed to the business of medicine —
MR. REYNOLDS: And a doctor would do that better then I would, that’s good.
DR. COHN: Or these people presume to do this better then you might. Steve and others?
DR. STEINDEL: Harry, I’d like to distinguish in your comment because a lot of what’s involved in the information that can be provided for this drug, for this knowledge base and decision support is factual. And that can be presented and we can talk about standards and we can put those forward as standards. Now how it’s implemented, now that’s where the problem is because that directly touches on the art of medicine. And I don’t know how much we can comment on that except to note that we are aware of this.
DR. HUFF: Be clear, I mean there seems to, there’s the potential for confusion here, line 74 through 87, okay, the thing that’s talking about drug knowledge base message, those are messages that are coming from the knowledge base vendors to people who are implementing, this is patient specific, this is like how you would distribute a knowledge base, this isn’t patient specific advice. So I think if I were, for instance just to say, I would say this is probably a low priority category for us because the other things are more important I think in terms of eligibility and benefits and scripts themselves, this is talking about a distribution format for knowledge which I think is important but I think it’s probably a secondary important, people can figure out work arounds for this for a while where other things I think are more primary to our purpose —
MR. REYNOLDS: That stated my point much better then I.
MS. FRIEDMAN: And I would just note that this is very much an evolving and volatile area.
MR. REYNOLDS: I haven’t seen any area of medical knowledge that isn’t.
DR. HUFF: I’m just jumping ahead, my only comment is just to make the distinction because I don’t want to get into a big discussion about the priority of that but to make clear what this was.
DR. MONTIAKAN: But you know Stan given that you just said that since dose and guidelines, weight and age were in the law, maybe I should make sure then that I reflect weight and age dosing guidelines in the messages for the prescriber —
DR. HUFF: They may be misplaced here, you’re right.
MR. BLAIR: The other piece, and maybe Stan you and Margaret you could help us with this, is I had the perception that a lot of existing e-prescribing networks while they’re providing great value and they’re moving quickly, they decided to move before a lot of the physicians have electronic health records so they basically worked around that and it appears as if a lot of these messages are, from the drug knowledge base vendors are going to the pharmacists and from a patient safety standpoint I think that we would feel much more comfortable if they were going to the physician or the EHR system and I think we have to be sensitive to not just the fact that they’re there and they have the data we want but are they getting to the right entity, whether that’s the EHR or the prescriber for them to make that decision.
DR. MONTIAKAN: Yeah, so really we need them under both if we’re going to be complete.
DR. STEINDEL: I have a comment about what you just said which will probably upset the physicians in the room, you’ll probably get a lot of the Form D’s that will say the information is better left to the pharmacists —
MR. BLAIR: And they’ve said that, I’ve already heard that, and that is —
DR. STEINDEL: That’s one of the tensions.
MR. BLAIR: Now they will say it in the context of they’re a double-check, but right now they’re not a double-check, in some cases they’re the only ones getting it and that’s a concern.
MS. FRIEDMAN: And that also relates to the comment we’ve heard about how much information is enough, or how much is too much, where is it good to have a certain amount of information that really doesn’t go to the doctor, where it’s not too much information overload, where its not feeling like it’s insulting his intelligence, and where does that all begin and end.
MR. VIGILANTE: A lot of the ROI of this whole endeavor lies in this block of information in terms of safety, quality, return for savings —
DR. MONTIAKAN: Moving on, the next category is laboratory, you’ll notice I don’t have anything under there and it was simply there because in several cases we indicate there’s drug/lab interaction information and if we don’t have the laboratory we’re not going to get any lab data. So I put laboratory there and I need to flesh that out probably a little bit and hope that maybe Stan could help me. Should I just maybe put HL7 there and be done with it or what shall I do?
DR. HUFF: I think one of the suggestions would be that, I mean there are a bunch of these things, again, as you pointed out that people have used different names for and they talk about EHR data and they talk about, and to me I would probably have clumped a bunch of this together and said it was clinical data like the weight and the age and my lab results and any of that sort of stuff, I would have said that’s “clinical data” or “clinical observations” and said you send out an HL7 and be done with it, probably collapse a bunch of rows into that one category.
DR. COHN: And you include age in that.
DR. HUFF: Yeah.
DR. MONTIAKAN: Which I actually do have in the terminologies but not in the message standards.
DR. STEINDEL: Stan, keeping this into total system picture, would you look at it as HL7 or would you look at it as a HIPAA claims attachment format? Because then we have extended information that’s coming from the enveloping as well as the HL7 message, a lot of which fits in with what we’re looking at.
DR. HUFF: I’ve got to try and get my head around that —
DR. COHN: Well, let’s keep it as a question.
DR. STEINDEL: I mean that’s a question, it’s not something to answer on this phone call.
DR. MONTIAKAN: I’ll annotate it and we can mull it over.
DR. STEINDEL: We haven’t put together the pieces yet, obviously it’s the first time its raised.
MS. FRIEDMAN: We didn’t hear that from the testifiers, this is just something —
DR. COHN: And it’s something the testifiers —
DR. STEINDEL: — are not going to be attuned to.
DR. MONTIAKAN: Okay, so then the last category of messages is health IT vendors, these are the practice management system, EHR, e-prescribing vendors, and they receive formulary, they receive, an interface really isn’t a type of standard I guess, it seemed to be an important issue for people. And then record retention, disposition, discovery, down time and recovery procedures was mentioned and you’ll notice under existing standards I put that state statutes provide record retention, disposition and discovery and HIPAA includes down time and recovery procedures, I wasn’t sure that the category which came from only one testifier was really needed in the message standard.
DR. HUFF: I think that one I would have placed down in the other category of what I call functional requirements.
DR. MONTIAKAN: I’ll move it there.
MR. BLAIR: Margaret, I’m sorry, let me let you digest that and then I have a question.
DR. MONTIAKAN: Okay, Jeff.
MR. BLAIR: Where we said health IT vendors do we really mean health IT systems?
DR. MONTIAKAN: System vendors.
MR. BLAIR: You mean the vendors as opposed to the systems.
DR. MONTIAKAN: Right. So they would have the capability of imbedding a formulary and creating those interfaces.
MR. BLAIR: Like an EHR system vendor.
DR. MONTIAKAN: Right. So I still think that that section on record retention stuff is better under functional requirements.
DR. COHN: It sounds good, it sounds like it’s part of security HIPAA.
DR. MONTIAKAN: Yeah.
DR. COHN: Okay, let’s continue on.
DR. MONTIAKAN: Terminologies is a major type of standards and there are drug terminologies and under drug terminologies we had package drug, clinical drug, nurik(?) informed, brand only, ingredients and compliance packaging form. And then we —
DR. HUFF: What is that compliance packaging form mean?
DR. MONTIAKAN: That’s, and I didn’t put that and I should have under the standards, that’s the label, I’m sorry, I need to add that.
DR. COHN: You probably didn’t know that was, NLM here didn’t know that was the label.
DR. MONTIAKAN: Structured label, yeah, I didn’t put that, I’m sorry.
DR. COHN: That’s fine, at least we know it’s here now.
MS. FRIEDMAN: Should we go back and call it that?
DR. COHN: Should we call it that?
DR. MONTIAKAN: I’ll put it in as existing standard structured label from FDA. Then in addition to drug we have therapeutic classification, we have sigs., oh that’s where I put the structured label, now why did I put compliance packaging form —
DR. NELSON: Is compliance packaging form the thing you mean like a Medra dose pack? Where you give somebody a package and it says take it according to the way the package is structured to give it to you?
DR. MONTIAKAN: Yes, yes, yes, that’s right.
DR. NELSON: I call those things drug delivery devices.
DR. MONTIAKAN: Drug delivery devices —
DR. COHN: That means something completely different —
DR. MONTIAKAN: So is there a standard for that?
DR. NELSON: It’s in Rx-Norm.
DR. MONTIAKAN: Okay, cool.
DR. COHN: Okay, whatever we decide to call it. Okay, continue.
DR. MONTIAKAN: Okay, let’s see, we’ve got sigs. including the structured label, should the structured label be under sig. or separate?
DR. COHN: I think it’s a very separate thing.
DR. MONTIAKAN: Okay, I’ll make it separate.
DR. HUFF: Now down below where you have over the counter, is that over the counter drugs?
DR. MONTIAKAN: Yes.
DR. HUFF: I would put that up under drugs too then.
DR. MONTIAKAN: Under drugs, gotcha. Okay, then we have devices and we have damian(?) supplies and there’s some thought to grouping those together but then they were talked about separately.
DR. COHN: Let’s leave those separate for the moment just because sometimes the code sets are different, as we’ve just been discovering.
DR. MONTIAKAN: Then I have complementary therapies, that would be your aromatherapy and stuff. Order sets, including other resources like diets and PT and so forth. Samples and other components not officially dispensed, should that go under drug also?
DR. HUFF: I wondered about, I mean the samples that are dispensed I think would all be named by one or more of the things that we had above, now I don’t know what you mean by other components.
DR. MONTIAKAN: I think this testifier was suggesting, and maybe this ought to be two separate things, that samples not officially dispensed should be maybe one, and then other components to me sounded like ingredients but they had identified them as with samples —
DR. HUFF: This to me is like a behavior we’re trying, I mean what I thought the intent of the testimony was is to say we have to have messages or we have to have processes in place that capture samples that are given out —
DR. COHN: So that people actually know about them.
DR. HUFF: — those things that are actually prescribed. But I didn’t think, I don’t know that this makes any new requirement for the terminology per se, it’s talking about a process that we want to enforce —
DR. COHN: Well it’s actually almost a message issue.
DR. HUFF: Yeah, I mean it talks about, you’re saying you really want a message or, yeah, you want a message or you want a way to transmit to somebody else that you gave out a sample, and that’s, but I don’t think it implies any new terminology per se.
DR. MONTIAKAN: Okay, I’ll put it under message. And other components, that would be like flavors, should I just strike that and put that under ingredients?
MS. FRIEDMAN: Fillers and binders —
DR. HUFF: Oh, that, how would we —
DR. COHN: That’s in ingredients, we’re all in agreement that’s ingredients.
DR. MONTIAKAN: Okay.
DR. COHN: Is that not ingredients, Steve?
DR. STEINDEL: I think is something that we, it goes back to the other discussion, what part of, what they were talking about was a physician ordering a drug and they want a convenient terminology to use for ordering a drug. Now what it translates to at the back end might be something different then what they present as an interface, and I think what we, we need to differentiate between the two and for example like if we are using Rx-Norm to represent the clinical drug that is being ordered and we use an Rx-Norm form for cherry flavored ampicillin well I don’t think Stuart is going to have all the flavors for ampicillin as a separate Rx-Norm, we may recommend that the flavoring go as a separate component in the message like we were just talking about sample might go in a separate component of the message, so that the system will work out well. And I don’t know that yet, I think we need to investigate it.
DR. MONTIAKAN: Well maybe I should keep other components example flavors as a separate line.
DR. STEINDEL: I think so at this point in time.
DR. COHN: And just have it near ingredients.
DR. STEINDEL: And near ingredients, yes.
DR. NELSON: But there are other kinds of instructions that might come with a prescription as well, it’s like saying lactose free or without alcohol, that are not to include but exclude —
DR. COHN: Let’s not solve this problem, I have one questions and then I want to get you back into this thing because we’re beginning to run out of time, and it just had to do with the order sets, which I find myself sort of going, I mean I guess we need to have them listed but order set sounds to me like we’re getting sort of far away from prescribing and this gets to be more of the general functionality of an EHR, that you’re ordering a lab test, you’re ordering physical therapy, you’re ordering a consult, I think we may be pushing the e-prescribing envelope a little bit.
DR. MONTIAKAN: How about if I put it under functional requirements?
DR. COHN: Yeah, as a question.
DR. HUFF: Well I wouldn’t move it, the way it’s stated I agree with you, Simon, but the things that I think is real and maybe should take its place here is you have, if you’re going to support these in a system you have what I would call a fully specified order, which consists of a drug code, it’s normal route and it’s normal frequency, and you can have a code for that, so essentially it’s a code for a usual normal prescription. And we may not want to do that but that’s a real thing that you have in working systems.
DR. COHN: I guess I’m just looking at how it’s specified right now isn’t what you were just saying.
DR. HUFF: That’s right.
DR. MONTIAKAN: So I’ll add what Stan said and I’ll move order sets to functional requirements.
DR. HUFF: Good idea.
DR. COHN: So let’s continue on —
DR. MONTIAKAN: And then we have under terminologies/drugs we have compounded pharmaceuticals and those engineered and tailored for genetics ARBs(?) —
DR. HUFF: I think that’s the message type because the compounded things are just made up of, it’s not a new identifier because the compounded things are made up of ingredients that we already set up above, we need identifiers for. So this is a kind of message we have to support.
DR. MONTIAKAN: Then in talking with Jeff a little bit it seemed like it was important to distinguish medical history and medication history so I have medical history by diagnosis, problem with lab results, clinical findings, and then manifestations of adverse drug events, indications like drug, diagnosis/drug relationships, drug allergy groups, drug interaction groups, drug/drug, drug/food, drug/lab, and then that’s sort of the medication history.
MR. BLAIR: Let me explain, it’s not that it’s my preference to divide them that way, it’s that that’s what the law laid out for us.
DR. HUFF: I think that’s fine.
DR. MONTIAKAN: And then the last thing I have under here seems sort of out of place but claim rejection reason codes, one of the testifiers indicated that was absent except I thought that existed in X-12. But I left it here because I wasn’t sure that maybe NCPDP doesn’t have it —
DR. COHN: Well, why don’t you, it sounds like we need to do additional research on that. Steve?
DR. STEINDEL: I have a question about medical history in general and that is I’m not totally certain under the Medicare Modernization Act what is required in terms of medical history, whether it’s medical history with respect to the drug that’s being ordered, or medical history with regard for checking as to whether or not the drug is appropriate for that person, like they have an underlying condition that might preclude the use of that drug.
DR. MONTIAKAN: The indications?
DR. STEINDEL: Those are two separate questions and from what we heard from the testifiers they actually represent two different levels of granularity and possibly two different code sets.
DR. MONTIAKAN: Right.
PARTICIPANT: What are the two options, it’s indications —
DR. STEINDEL: Indication for ordering the drug, like for instance if you’re ordering a hypertensive drug you just put in the ICD code for hypertension. But if you’re talking about ordering a drug that you may not want to give to a person who has impaired renal function or something like that, that’s a more complete medical history and I’m not sure what’s really required, I know what’s required for the EHR point of view and what we totally want and that’s the full medical history but I’m not sure what’s required from the Modernization Act.
DR. COHN: I don’t think it specifies. If we want to we can certainly ask, go back to Congress, I think there are people from Congress who’d be happy to come and tell us what they thought this meant —
MS. FRIEDMAN: They may have left it intentionally loose to build —
DR. STEINDEL: I think we need guidance from CMS.
MS. TRUDEL: I would say provide information on both.
DR. COHN: I think it’s different levels of functionality —
DR. STEINDEL: We can separate the two.
MS. TRUDEL: When you’re looking at this it’s not a set of requirements that everybody has to do, there’s almost that pyramid thing again where we would expect that the highest level of functionality would certainly encompass all of that.
DR. STEINDEL: Well, we’ll accept that as guidance in order to structure the letter.
DR. COHN: Margaret, believe it or not we have about 90 seconds, so can you help us —
DR. MONTIAKAN: Okay, the very last set of types of standards are functional requirements and basically those are things like the HL7 draft standard for trial use, clinic health records, your e-prescribing application levels, some of the things we talked about will move into there. Performance testing, standards tested, network interoperability, and then I started a little bit on signatures but didn’t get too terribly far on that. But basically those are the types of categories of standards I felt that it was really critical to have a solid sense of what those were and then I filled in the rest of the columns, existing standard, standard limitations, standard gaps, testifier recommendations and source, and obviously we will continue to do that with the rest of the testimony coming.
DR. COHN: Steve, you had a question?
DR. STEINDEL: Simon, no my comment on signatures is that there are a lot of states that are doing e-prescribing at this point in time and they must have some type of electronic authorization, whether it’s a signature or not, and we need to separate that from the DEA requirement for controlled substances.
DR. COHN: And I think probably in October we’ll start talking about some of that stuff.
MS. FRIEDMAN: And there’s a distinction between the digital and the electronic.
DR. COHN: I want to get this meeting over, I’d like to give us all a chance to break before we start again.
DR. HUFF: A quick comment, in the note it says that NCPDP script has an XML format and I don’t think that’s true —
DR. STEINDEL: I don’t think it’s true either.
DR. COHN: So Margaret, can you check that for us?
DR. MONTIAKAN: Well, one of the testifiers said that but I can check with NCPDP directly.
DR. HUFF: I think they said that they made their own XML format for that but I don’t think that’s a part of script standard, they were doing their own thing in XML, I’m pretty sure they don’t have an XML —
DR. COHN: Stan, thank you, we really need to wrap up now. Remember, there’s October hearings also, we’ve got December hearings, what we are going to do though shortly is to begin to query people for dates for the first half of 2005 so be aware of that —
DR. STEINDEL: And we’re still looking for the NCVHS Georgetown Mansion.
DR. COHN: Exactly, we will try to get it back down to two day hearings from four, now once again the next set of hearings is July 28 through 30th, see you there, thank you, Margaret, thank you and Stan thank you for being on the phone. I think we’re making progress.
MR. BLAIR: Simon, I think a small group of us need to get together and talk about a format for a conference call, as Steve said we need get the framework ready prior to the July meeting and we’ll let folks know, maybe the end of next week —
DR. HUFF: I don’t have those conference call times on my calendar —
DR. COHN: I don’t think they’ve been established —
DR. STEINDEL: We haven’t set them up yet.
DR. COHN: And we will as usual try to hold these things to a minimum, just because a lot of us have a lot of face to face meeting time. Okay, thank you everyone, let’s take a break. The meeting is adjourned.
[Whereupon at 9:54 a.m. the meeting was adjourned.]