[This Transcript is Unedited]
HHH Building, Rm. 705A
200 Independence Ave.
Washington, D.C.
Call to Order and Introductions
Report to Congress on HIPAA Implementation and Plans for 2000
MR. BLAIR: Good morning. This is the National Committee on Vital and Health Statistics. This is the second day of the meeting of the CPR Work Group.
Yesterday we went through a number of issues and recommendations that will be folded into the first draft of the report to the Secretary that is due by August of next year. This morning for the first couple of hours, we are going to be finishing off that process and reviewing some of the items that were a little bit difficult to come to consensus on yesterday. So we are going to be running until 10:15.
At this point, let me go around the table and just let everybody introduce themselves. I'm Jeff Blair at the Medical Records Institute, Chair of the committee. Dr. Cohn?
DR. COHN: I'm Dr. Simon Cohn. I'm with Kaiser Permanente, a member of the committee and chair of the Subcommittee on Standards and Security.
DR. FYFFE: Kathleen Fyffe, member of the committee as well as the work group on the computer-based patient record and the Subcommittee on Standards and Security, and I work for the Health Insurance Association of America.
DR. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC and executive secretary to the committee.
DR. YASNOFF: Bill Yasnoff, CDC, staff to the work group.
AMATAYARUL: ... contractor to the work group.
DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for information technology to the Agency for Health Care Research and Quality, liaison to the national committee and co-lead staff of the computer-based patient record working group.
MR. BLAIR: Is there anyone else in the room that we should have introduce themselves?
DR. FITZMAURICE: No one else, Jeff.
MR. BLAIR: There is no one else, okay.
DR. FITZMAURICE: We've outlasted everyone, Jeff.
MR. BLAIR: Well, for those of you who are listening in on the Internet, we went until 8 o'clock last night, trying to cover as many things as we can. We will continue on this morning. Margaret, maybe you can kick off, you can start again as to where we left off yesterday.
AMATAYARUL: We left off with the section on privacy, confidentiality and security, which is the last section. There are three issues. We identified that recommendations were not applicable for this section to reiterate the NCVHS position on the issue, with the expectation that there would be some verbiage made from the work group relating to privacy.
This actually relates to the question that I had earlier that I'm not sure we fully addressed, that is, do we make recommendations for issues relating to other work groups, or do we just incorporate the comments that we have received from them as contributions?
Anyway, if you would like, I can read the issues.
DR. COHN: I didn't understand exactly what your last comment was, so maybe you can clarify that a little further; do we bring up our own recommendations or do we ask the -- do we shy away from recommendations in these areas?
AMATAYARUL: Well, for the diverse state laws, we received an about three-page paper that Kathleen had written that was summarizing the issues with respect to diverse state laws. It was my understanding that there is a privacy work group and an NHII work group. It wasn't clear to me whether there were going to be papers from those work groups contributing to this document, or whether you wanted to develop your own recommendations within this work group that relate to other work groups.
MR. BLAIR: With respect to the state laws, that had been something that had been longstanding, that Kathleen Frawley had indicated she was covering as something that could be contributed as a document.
The understanding that I had from back when we were discussing our focus areas was, they were intended specifically with respect to NHII and data security, where there are other groups within NCVHS that are addressing those. Because they were related issues, they felt that it should be referenced in our report as a focused area, but that we should point to the work of the other work groups, as opposed to trying to do independent work ourselves. At least, that was the recommendation that I had back in December of a year ago.
DR. COHN: Can I maybe change that wording a little bit? Because I tend to think of it as summarize appropriate work, and if there are issues that are unique in relationship to patient medical record information, then we need to be aware of them. We may want to take the lead on some of it, but we may also want to involve the appropriate subcommittee at that point, if there is another issue.
MR. BLAIR: That's good. That's a good refinement. Were you able to capture that?
AMATAYARUL: Yes. So the first issue is, virtually all testifiers identified that confidentiality protections were needed for patient identifiable health data, in order for health care information systems to be widely accepted.
The second issue is, several testifiers reported that use of offshore transcription programming and other information services is a significant privacy concern with respect to electronic PMRI.
The last issue is, several testifiers expressed concern that re-use of data through mining of stored transcriptions, pharmaceutical databanks, remote connectivity options, application service providers, data repositories and other sources of electronic PRMI is a significant privacy concern.
MR. BLAIR: Comments?
DR. COHN: I actually think that they are all valid issues. I think of the three, I would think that the first and the last are things that probably we could summarize appropriate work from other groups or privacy MPR, et cetera -- actually, the NCVHS recommendations on privacy.
Item 41, which has to do with offshore transcription and other information services, is I think an area that is not covered by any of the other groups, and we probably need to think about what sort of issues and recommendations we may want to forward on those.
DR. FITZMAURICE: I saw these as global issues. The confidentiality might be best addressed saying that we recognize that confidentiality is a concern and will not be the specific focus of this report, since it is being covered elsewhere. We refer you to -- and much the same thing as you suggested.
On the offshore and the re-use of data, that might also be part of a larger topic. That is, as there is a growth in electronic commerce and electronic exchange of information, it is important that it be protected even outside the hands of those who originate it and those who use it. There are people in the middle who process it, add value, and we recognize that concern.
I don't know that we have specific recommendations to make, except that they keep it secure.
DR. YASNOFF: Two very brief comments. On 41, I certainly see the problems with offshore transcription and other information services. But I don't see the problem with offshore programming. Offshore programming does not inherently involve information, patient medical record information. If somebody is doing programming, they can use test data. In other words, you are not really sending confidential information.
DR. COHN: I apologize, there were three things going on back here. What I think you said was that offshore programming was not an issue?
DR. YASNOFF: Right, that's exactly what I said. Offshore programming is not an issue. So I'd like to cross that out.
The other thing is, I think we should refer back to our recommendations with respect to data integrity and accountability, and point out that those are related to the issue of confidentiality. In other words, we want to be sure that -- let me put it this way. Confidentiality policies are implemented by security. So the data integrity recommendations we have could be viewed as security policies. So we are already recommending mechanisms by which confidentiality policies, whatever they are, can be in part carried out. So I think we should reference that.
DR. COHN: Margaret, did you capture that?
AMATAYARUL: I was going to suggest that if you did want to do something, make a specific recommendation regarding offshore activities, we could reference and expand the state diversity as well, in addition to looking at how we exchange information across states, but we could add "and globally" to that.
DR. COHN: I personally believe they are very different issues, but I wanted also to make sure that you captured the fact that -- Bill made a very important point here which I hadn't thought of, that the data integrity piece is really security. That is how we are going to help assure security.
DR. YASNOFF: It's a part of it.
DR. COHN: Or it's a part of it. I think the relationship between it begins to make that whole piece a little more interesting.
MR. BLAIR: Marjorie?
DR. GREENBERG: I was just thinking in relationship to the offshore transcription or other information services that might involve PMRI, that the privacy and confidentiality NPRM refers to the concept of business partners. It seemed that concept could be extended to this as well, that they are required to follow the same principles.
DR. COHN: I agree that that is an interesting idea. It may very well. I'm not enough of a lawyer to know whether or not when you start dealing with international environments, how that plays out.
DR. GREENBERG: But something like that should be in place.
DR. COHN: We might ask for a legal opinion to see if that indeed does cover that situation.
DR. FITZMAURICE: The European directive says that countries that receive personal data from Europe have to protect it as well as it would be protected in Europe. So there is a precedent in that regard.
MR. BLAIR: Any other comments? I feel like this starts to roll back on an item that we tended to dismiss yesterday with respect to state laws. It was retention and permanence of state records. I think we considered for a little while, maybe there were system functions, but we have a very mobile population. As people travel, if they wind up living in one state and they move to another and the permanence and retention of records in that state is different from one to another, as well as electronic signatures and all these other things, it becomes a problem.
So I think this thing about offshore privacy also deals with this idea of the lack of consistency for legal regulations reflecting patient medical record information. So I think maybe I'm going back to that other previous bullet, since we seem to follow from bullet to bullet. I just wanted to make sure that the permanence and retention of records across state lines was not eliminated or dismissed as an issue or recommendation. I don't know what the status was, Margaret. Maybe you could tell us.
AMATAYARUL: We deleted it.
MR. BLAIR: You deleted it? I would like to -- I would call, if the group would agree, that I think that should not be deleted, that that is an issue that creates a problem. If we don't state that it is a problem, then there is no one else to come forward and do that. What is the thinking of the group? Am I alone in this?
DR. FITZMAURICE: I don't know that we have seen an awful lot that says how big of a problem it is, but I can see that uniformity would be generally desirable. I don't know why a state might gain by having a six-year retention, other than by having tenure retention. I'm not sure what the problem is, given that things can be stored so easily electronically. I'm open to it, though. I'm not dismissing.
MR. BLAIR: Margaret?
AMATAYARUL: I think that instead of looking at this from a legal perspective in terms of the statute of limitations, the issue here was with respect to a number of providers who are currently deleting files immediately upon discharge of a patient, because they have printed them out and they consider the printout the legal medical record, but thereby losing all of the audit trail capability that they may have, if any, in their system. So the retention issue was that we don't have the ability to go back and audit a record online, because of some policies of not retaining that.
DR. COHN: Is that the same issue? That seems like a different issue. As long as they are retaining it in some form, I don't see anything in the recommendation that says that it has to be retained or made permanent in electronic format.
AMATAYARUL: No.
DR. COHN: Are you suggesting a regulation that says if you have it electronically, you can't put it down into paper format and then erase it off the hard disk?
AMATAYARUL: No. The issue really was simply that all the electronic data you capture does not necessarily get printed out when you print out. So if you delete that, you are deleting the ability to do audit trails, even in some cases I've seen where people have embedded practice guidelines into systems and not all of the detail regarding the documentation in the practice guidelines gets printed out, because of systems problems.
So the issue was maybe not so much belonging in this section, but someplace. If you enter data into an electronic system, you should be able to retain all the data in some form.
DR. ZUBELDIA: Doesn't the privacy NPRM require retention of the other trails? I thought I read that somewhere. The privacy requires retention for six years or something.
MR. BLAIR: It requires retention of the audit trails, but does it require retention of the original information that the audit trail pertains to?
DR. COHN: If I can just make a comment. Obviously this is not where we started the discussion this morning, and I don't personally have a strong feeling that we should necessarily take this part out. I'm not sure it is worth a long discussion. I think if it indeed was going to be left in, there needs to be a little more fleshing out of exactly what the issue is that we are seeking to solve. I sense, Margaret, that you feel this is an issue.
So my personal feeling anyway would be -- and if Jeff thinks it is an issue, I say flesh it out and we'll talk about it in January, and maybe we should go back and talk about 41 now.
Can I make a comment about -- or just go back to 41 and make a comment that I wanted to make about this one, because I think it is an important issue. I just don't know whether it is handled by privacy regulations or not, so I think that really, the action here is that as a first step, we ought to ask for some sort of a legal opinion about whether or not the parts of the privacy reg that relate to the business partner relationships covers this issue, and therefore we can just relate that, or whether this is still left as an open issue. That would be one thing that I would like to see on this one.
DR. ZUBELDIA: I'm not going to give a legal opinion, but the privacy reg does not cover providers that do not engage in EDI. So to that extent, if providers maintain their claims filing and eligibility and all of that with traditional methods, even if they are doing offshore transcription, they would not be covered by privacy.
DR. GREENBERG: I was actually suggesting that that concept might be one that you would want to endorse of the business partner concept, not necessarily that the current privacy regulations would cover this. But that seemed to be maybe an appropriate concept of the relationship that should exist.
DR. ZUBELDIA: We discussed this during the meeting last week. With the trading partner or business partner contract, you can put some penalties in the contract as a business partner, but sometimes you cannot enforce penalties, and you can certainly not put a general term as a contract clause. So it is pretty weak.
DR. GREENBERG: Well, probably internationally your ability to enforce is much worse.
DR. COHN: Anything else on 41?
MR. BLAIR: Margaret, how many more do we have to go?
AMATAYARUL: We're done. We need to go back for the beginning.
DR. COHN: Actually, I don't think we are done. I have 44, what about 43?
MR. BLAIR: Forty-three through 46?
AMATAYARUL: We deleted those and moved them elsewhere. Those were the items that we had originally in something we called standards development process, which was not a scope, not a focus area. So we attempted to move these to areas where we thought they belonged.
MR. BLAIR: Then I think we are about to revisit the first four items in the message format, where we had some difficulties and we needed to go back and make sure we had consensus. Simon, was that correct?
DR. COHN: Yes.
MR. BLAIR: Then, Margaret, maybe you can bring us back to where we are, in terms of what we have been able to capture and what our status is.
AMATAYARUL: Okay. We had an issue that, while most testifiers agreed that considerable progress has been made to achieve interoperability in patient medical record systems, the message format standards -- it was also felt that these standards have not achieved true plug-and-play capability yet, which one pointed out was a hardware issue. Users are compensating for lack of plug-and-play capability by employing bilateral agreements to make message formats standards work.
The sense that I got was that the issue here was really to focus on bilateral agreements to make message format standards work. We also identified that item 10, which was relating to conformance testing, should be brought up here. Also, number two, which is, many testifiers expressed a need for frameworks, architectures and models to help coordinate the operability among message format standards, et cetera, should be merged.
MR. BLAIR: When he objected to the plug-and-play and he said that was a hardware issue?
AMATAYARUL: Yes?
MR. BLAIR: From a terminology standpoint, I think that is just fine. It feels like it in a sense has got to be both hardware and software. What if we were to change the word to -- he didn't object to interoperability, and I think the thought was that interoperability is a continuum, and maybe if replaced plug-and-play with complete interoperability --
DR. YASNOFF: Jeff, can I suggest some language for that? MR. BLAIR: Pardon?
DR. YASNOFF: I wanted to suggest some language for that that I think might express it better.
MR. BLAIR: Sure.
DR. YASNOFF: How about seamless, unsupervised data exchange?
MR. BLAIR: Fine, good. Is everyone else comfortable with those words?
DR. YASNOFF: I agree with Clem that the plug-and-play term really does apply to hardware. Although we understand what it means, I don't think we want that kind of terminology in the report. So I think this expresses it.
MR. BLAIR: Good. It sounds like everybody seems to agree with that.
AMATAYARUL: Yes.
MR. BLAIR: What about the recommendations under there? Did Clem have some objection to the recommendations?
AMATAYARUL: What we did to the recommendations, so far, anyway, is, A, the NCVHS should adopt guiding principles for PMRI message format standards that enable complete interoperability with bilateral agreement should not be necessary. We added, government should adopt message format standards. There, we need to be a little bit more specific, I think.
Then implementation guidelines to assist in the use of message formats, standards of medical terminologies will be needed.
DR. COHN: Then we are probably adding conformance there, also.
AMATAYARUL: Yes.
DR. COHN: Conformance is another piece. Can I make a comment about B? I think they are pretty good. To me, the big question is, what do we do about B?
MR. BLAIR: Could you repeat B?
DR. COHN: B, government should adopt message format standards. Anyway, the discussion which has nothing to do with what is up on the screen, is the discussion we had yesterday about how specific we are going to get and what we were going to need to do to get more specific. I think we had all agreed yesterday that we are going to try as much as possible to move from so-what recommendations into things that were actionable and that can make a difference.
So the question is, beyond the issue of should government adopt message format standards, I have some thoughts, but I think we need to raise the general issue of how we need to move from where we are now as a work group, having had a number of pieces of testimony, to being able to recommend to the Secretary whatever standards need to be recommended. I don't think we are in a position right now to do that. I think there has been some discussion that perhaps we need to talk to whatever standards groups we think -- or somehow send a communication to some of the standards groups that we are interested in doing this, and invite them either to testify or present the standards that they feel are mature and should be considered for national standards, that maybe either have or could have by the time of implementation guides, and would be capable of conformance testing. It is maybe something that we need to get them in to testify what these standards are.
Anyway, that is one set of thoughts. Do people have opinions, thoughts, about how we should approach those?
MR. BLAIR: My additional thought on that as a process for how we could approach it is, we did seem to agree on the addition of certain guiding principles to complement the ones that Michael already had for PMRI. Those I think could be the criteria that we use in the selection process. I think that that would give us at least some guidance, some criteria for our selection, so we're not just doing it arbitrarily.
Maybe Margaret, in the next few weeks, if you could pull together an updated list of guiding principles, so that we could look at them as a whole and see if they would assist us in that process. Simon, how do you feel about that?
DR. COHN: Kepa has his hand up.
DR. ZUBELDIA: Maybe part of the process could be to ask HISB to invite some of the representatives of the candidate standards to give us a presentation on why the standards should be allotted, and have them help us define what the guiding principles should be. That may be a little self-serving, but these are the folks that are going to have their standard as part of the recommendation.
MR. BLAIR: How would that be different than the testimony we have gotten from the SDO's last December, last March, and in June, where they went through the questionnaire and gave the definitions and they indicated what was important. I feel like we have heard from them quite a bit.
DR. ZUBELDIA: It may not be necessary.
DR. COHN: I think, Kepa, what you are asking potentially is a critique of what we think the criteria should be.
DR. ZUBELDIA: Working together with them in defining those criteria.
MR. BLAIR: Maybe we could send out the criteria to them and have them critique it?
DR. COHN: That's true, comments. Part of it is that, part of it is how specific do we want to get. At least in my view, as I think about this process, the good news is that I don't think we need to have specific standards by February. I don't think we need to go to the next NCVHS meeting having had this discussion. But I think it is something that, if we do decide we want to do between February and June, with the final recommendations, we need to have this discussion.
But as I said, I want to find out from people whether it is something we should get involved in or not. I see Bill has his hand up.
DR. YASNOFF: I have a slightly different issue, so why don't we get some answers to your question?
DR. COHN: To me, the question is, is this a path that the work group wants to take, and is this the right level of specificity. We shouldn't do it if people don't want to do it.
DR. FITZMAURICE: It might be that by establishing a preliminary cut at the criteria and getting them somewhat vetted, and outlining what the process could be, we recommend to the Secretary that the Secretary initiate and continue such a process to identify standards, to evaluate them as they come along and as they mature, so that decisions could be made about clinical standards the same way they are about HIPAA standards. That way, it doesn't put us on the line to make a recommendation at one particular time, and that might not be the right time for a recommendation for a given standard. It also says, we need to be concerned in having the HIPAA process clinical standards as well as administrative standards, as long as they promote efficiency and improve the quality of care.
DR. COHN: Can I just ask you a question just to follow up on that one? I actually agree with you completely, because I think this needs to be a process. But do you think it makes sense, if there are currently mature standards?
DR. FITZMAURICE: If there are mature standards that we can agree upon? Yes, we should make a recommendation that these are the places to begin. But I wouldn't usurp the Secretary's process, that the Secretary isn't going to say, this committee recommended it, I'm going to adopt it. The Secretary probably would put it through her own process. So we want to encourage something that will continue. But it doesn't hurt us to say we think these are ready.
MR. BLAIR: One of the things that I thought I was hearing -- and I don't have strong opinions on this, so this is just a little portrait of some of the impressions, let me put it that way.
For the most part, the vendors and users are moving forward with message formats, and the marketplace is doing fairly well. I seem to hear severe criticisms, if we wind up saying that any message format standard doesn't have market acceptance. A lot of them seem to be saying, let's leave them alone.
My thought was that the area where users were winding up saying that they needed us to specify things seemed to be more in the medical terminology area than in the message format standard area. What is the sense of the group on that?
DR. FITZMAURICE: Jeff, could you repeat that? I heard what you said, but I'm not sure that I understood what you said.
DR. FYFFE: Could you repeat that and explain it a bit, Jeff, please?
MR. BLAIR: For the most part, message format standards have greater maturity, market acceptance. I think for the most part, the testimony that I heard especially from the SDO's was, leave us alone. I didn't hear the vendors saying that they needed to have the government adopt a standard for them to adopt message format standards.
I didn't feel as if I was hearing that government recognition of message format standards was needed to move the development of message format standards forward. I did hear that, or I thought I did hear that, much more in the less mature area of medical terminologies, where vendors were winding up saying that it would be helpful to them if the government acted as a catalyst, and wound up identifying the terminologies that would be the right direction.
Now, that was the impression I got, but that was not in Margaret's summary of stuff here.
DR. FYFFE: I'm a little confused by that, and maybe I'm taking a simplistic view of it, but if medical terminology includes ICD-9 and CPT-4, those are quite mature and well accepted. Now, if you are talking about other terminologies that are not in widespread use, and there are a few that are, other than those two, then I guess I would agree with you.
MR. BLAIR: Yes, and I was thinking in particular about those folks that were moving forward with patient medical records, that were looking for terminologies in that area.
DR. COHN: I'd like to make a comment about this one, because I think we are getting ourselves into a Catch-22. In some ways, these are mature standards, we don't want to deal with them because they are mature, and immature things that aren't quite ready, yes, people need help on them, but we also can't probably tell them what the standard is going to be. So we can easily come up with a blank page of recommendations, saying everything is going to be researched, further evaluation, 10-year demonstration projects. I didn't hear that that is what we wanted to do yesterday.
Now, I would make a very specific comment in relationship to these standards. Now, if indeed the standards were -- let me just stop for a second. Most people have adopted message format standards, utilizing their own implementation guides, individual developed.
I can speak for my organization. We have a large crew developing what effectively is an implementation guide for Kaiser Permanente and how we use some of these message format standards. What we have identified here as the issue is exactly that issue. I think that the standards we are trying to promote are standards that are not just the envelopes and not just, there is something that is going to be in this field, but you decide what that is going to be, but something that is specified with implementation guides, capable of being performance tested, that allows for moving from bilateral agreements. That is a different type of standard than has heretofore been on the market.
Now, maybe I'm wrong about that, Jeff, but if this problem were solved, we wouldn't be talking about interoperability. We would be congratulating everybody on interoperability, and moving on to the next issue. So to me, that is the issue. Just like with X-12 standards; we couldn't just say, X-12 -- you select the implementation guide, or you select the version as a standard. The government has had to get specific on what the implementation guide is.
MR. BLAIR: Simon, could I build on your thoughts? I agree with the track that you're saying. Let me go back; I don't have strong feelings against the adoption of message formats for us to recommend adoption, but I just didn't hear that as hitting at the core issues of what the problems were. The core issue I was hearing was that people were asking for increased interoperability of the standards, increased coordination of the standards, increased conformance of the standards, increased data integrity and accountability of the standards and data security. In other words, a set of interoperability and coordination and characteristics, improvement, but not -- those were the things that I thought were where the market said it was needing help.
DR. COHN: Are we talking about anything different? How do you get to interoperability except by what we have just been talking about, which is having a specific implementation guide, which is the definition of what the terminology is in it, and the ability to therefore do conformance testing, et cetera.
MR. BLAIR: Right. The only distinction was, maybe we should be concentrating on those issues as opposed to spending time to figure out which standards we would recommend people adopt. Instead, we focus on the interoperability, the quality and the coordination.
DR. COHN: I agreed with you until that last comment. So your recommendation would be that we not deal with any specific standards in terms of being able to recommend to the Secretary any particular standards, but stay more at the level of staying, STOs, we think you ought to develop implementation guides?
MR. BLAIR: Well, okay, let me bounce back a little bit here. Maybe we can recognize that HL-7 and Dicomm and NCPDP and a whole bunch of others recognize that they have a certain degree of market acceptance, and are doing a generally good job; however, testimony indicated that here is the areas of improvement and focus on the areas of improvement -- something like that.
DR. FITZMAURICE: That gets us into a critique of specific standards. I guess I feel I'd like to get a little higher level, and maybe direct the Secretary to look at these as the last of our list of priorities to be considered, and let the Secretary develop, if she wants to, what is right and what is wrong with the standards, because we can be right at any one point in time, but over the course of time that those questions remain, the inconsistency between what we have said and what they have done will stick out.
DR. ZUBELDIA: Something that has worked very well for X-12 is the fact that the Secretary adopts specific implementation guides, not for all the external transactions, but for some specific health care transactions. I think at this point, the situation with our mandate in HIPAA is that there is not a definition of what transactions to make standard under HIPAA for the MRI.
Maybe one thing that we can do is identify those transactions, those messages for PMRI that are ready to be standard, and recommend to the Secretary that the SDO's should have a set time frame of one or two years to come up with standard implementation guides that could then be adopted by the Secretary for PMRI, and put that Band-aid on the SDO's to extend the list that is for administrative translations into the PMRI, and have a list for PMRI.
DR. FYFFE: Thank you, Kepa, you said that very well. Again, I want to emphasize that if we want a certain outcome at some point in the future, we have to be as specific as possible. Short of mandating a certain standard or standards, I think the next step below that or before that is something along the line that Kepa has suggested, by saying that something has to happen within a certain period of time. That will focus the forces in the industry and in the government to get it done.
I think we really need to err on being as specific as possible, because I think that the testifiers and people that gave us input during the information gathering said again and again that the government needed to do something, and they were not happy with the way the situation is now. I don't think that we should perpetuate the way the situation is now, and instead try to be as specific as possible.
MR. BLAIR: Maybe I misunderstood. I agreed with what Kepa -- at least what I thought he said. I thought he went specific, but it wasn't that it was short of adopting; I thought he was going beyond adopting, just winding up saying, these are the ones that would be adopted, and in order for you to get the full approval of the Department of Health and Human Services, you need to go an additional step. We are adopting you with the idea that you will wind up improving your implementation guides. Did I hear you correctly? Which may be the approach.
DR. FYFFE: Yes, Kepa, if you could clarify.
DR. ZUBELDIA: I think we would say, this is what we think should be adopted once the implementation guides are ready, and then adopt the implementation guide.
DR. FYFFE: So the government is actually stating what the standard will be.
MR. BLAIR: And you are setting a criteria that -- Simon had the idea of candidates for standards and terminologies. If we refer to these as the candidates, --
DR. ZUBELDIA: I wouldn't say candidates. I would say, this is what you have to do.
MR. BLAIR: But aren't you indicating that we are specifying by name which SDO?
DR. COHN: But it isn't just the SDO; it is the actual standards. All the SDO's have lots of standards, but we have not implemented all of the ANSI X-12 standards. They have got probably another hundred that we haven't even talked about.
DR. ZUBELDIA: Use the attachments as a model. There is possibly hundreds of attachments. The attachments work group has chosen six specific attachments, and they are putting together the implementation guide for those. I think six is the magic number. An implementation guide for those, and then there will be more. Maybe we can start with a round of, what are the PMRI standards that need to be adopted now. If that requires specifying some HL-7 and some Dicomm and some other standards, let's specify those, and charge those groups with putting together an implementation guide that can be adopted within two years.
MR. BLAIR: Now, when you say a guide, you are through this process, so you may understand this better and already have included in your thoughts what I am about to ask.
The implementation guide in my mind serves several purposes. One is to lower the cost of implementation. Another one is to improve interoperability, and I would hope data integrity. Is there something when we would go forward with that where we indicate, not just that they have to have a guide, but they have to have a guide that would promote those objectives. Is that already in there somehow?
DR. ZUBELDIA: I think that is built into the implementation guide. The implementation guide assures that one entity sending transactions in the standard can do so without having a previous trading partner, technical test agreement with the one receiving transactions. Everybody understands what is in that transaction and that message.
MR. BLAIR: So those characteristics are in fact requirements with an implementation guide?
DR. ZUBELDIA: Yes. It has to be completely specific.
MR. BLAIR: When we phrase this in our report, do you feel like it would be helpful to indicate that it is not just a guide for a guide purpose, but it is to support those objectives?
DR. ZUBELDIA: Yes. I think the SDOs would understand that anyway, but I think it may be good to express it.
DR. COHN: The whole point of the implementation guide, without an implementation guide you don't have a standard, at least in my view.
DR. FYFFE: Can you repeat that, Simon?
DR. COHN: Without an implementation guide, you really don't have a standard.
DR. FYFFE: You don't have the detailed specifications for the standard.
DR. COHN: Yes.
DR. FYFFE: You can say there will be milk cartons for milk, but you don't say how big the carton is. That is very crude, but a standard is not complete without specificity of an implementation guide.
DR. YASNOFF: I have a couple of comments as I've been listening to this. I think I want to try to summarize what I am hearing, and then I have a couple of additions.
I think what we want as an outcome is for the Secretary to designate someone, perhaps NCVHS, to supervise a process by which standards are adopted in some priority order, and that the supervisory group, say NCVHS, would select those transactions from various standards that were high priority, insist on the development of a single implementation guide that would facilitate exchange of data, data integrity and would allow conformance testing, and then presumably we also want the Secretary to designate some other body to actually do the conformance testing, so then NCVHS could hand this implementation guide to the conformance testing agency, have them implement it, make sure that it really is done, and then would recommend to the Secretary that the government adopt this transaction from this particular standard.
That is essentially the process we are saying. But I want to add two things to this mix.
One is that I think you could again have the government lead by example, so that is the government proposes a particular transaction, that the government should have the responsibility of developing a detailed implementation guide that can be conformance tested. So let the government lead by example.
I am thinking specifically of the immunization transaction in HL-7 that was done by CDC. I believe there is an implementation guide, but I don't know that there is any conformance testing available, and that has been a problem.
So the government should be required, when it proposes these standards, and the government can go to HL-7 or X-12 just like anyone else and propose standards, but it should do it the right way.
The other thing is, when you say adopt by the government, I think we've gone through this point again, but there are at least four levels of adoption by the government, or maybe more. One is the use by the government within its own agencies for the government's own business. Two is, within its own agencies and in addition in all of the health plans that cover government employees, because the government is a purchaser of care, so the government can require the use of standards in its purchasing contracts.
A third level is in all health plans that are paid by the government, essentially Medicare and Medicaid. Then the fourth level is, the government of course can require the standard to be used by everyone in the entire country.
So I think we need to be specific about what level of adoption we are expecting, or whether this is going to be a sequence, so that it is clear to the Secretary exactly what we are recommending.
MR. BLAIR: Good clarification. It is my understanding that for the most part, with the financial administrative translations, it was the third level, is that correct?
DR. FYFFE: Fourth level.
DR. YASNOFF: Yes, it's the fourth level, but only for electronic data. So it is not all data by everyone. I'm not suggesting -- I don't know which level we should pick, but I think we need to distinguish that just using the word adopt in this report is very non-specific.
DR. FYFFE: Thanks, I appreciate that. That was very, very helpful to talk about the different levels. And we do have to be specific about that.
What I am going to say next I don't know if you all agree with. But it troubles me that if we are not very specific and if we don't go to the fourth level that Bill has talked about, that there will continue to be resources wasted in the health industry in this country, because organizations, agencies, whomever, will be developing or trying to develop processes and standards and so forth that are not the ones to be adopted. There is a lot of that that goes on, and it is very wasteful in the long run.
The good side of that at times is that there is innovation, and good things can happen as a spinoff. But I really professionally don't want to see any more resources wasted in something that isn't going to be fully adopted.
DR. YASNOFF: But Kathleen, don't you think that these different levels may require different timetables?
DR. FYFFE: Correct, yes, I do. But what I am talking about, and I'm looking at this in a kind of a binary fashion, black and white, if we put a stake in the ground and say that eventually everyone has to do the same thing, then it lessens the possibility that we are going to have waste in terms of people or organizations developing and innovating something that is not ever going to be used.
DR. COHN: Actually, Kathleen, I agree with you on this one. I think we are all for this sort of thing thinking about number four.
DR. FYFFE: Yes. And Margaret, somehow if we could capture that thought somewhere in the report and in the executive summary. Although I like innovation and the market and so on and so forth, in the long run we cannot afford in the U.S. to continue to be as creative as possible. We have got to put a stake in the ground and aim toward it.
MR. BLAIR: Is that the consensus of the group? If I heard you correctly, what you are saying is, the adoption that we should use is the fourth level --
DR. COHN: Though we might use three or two for testing or demonstration.
DR. YASNOFF: Or an accelerated timetable for the earlier -- it is much like what the President did in response to the IOM report on patient safety. He said, federal agencies, I want you to do something about this immediately, and I want to know within 60 days how we can do something more globally. So the federal agencies can act immediately. That is within executive authority, doesn't require regulation. but the eventual promulgation of new policies in this area to the entire country has to take some time. You have to give people time to adapt.
MR. BLAIR: Let me just ask one question. The nation is going through -- I think the right word is revolution with respect to the acceptance of the Internet. I know that there are attempts by some of the SDOs to modify their syntax, so that it could work over the Internet, but in some cases there are major architectural shifts.
Do we feel so confident at this stage that existing message format standards will be most appropriate to serve over the Internet?
DR. YASNOFF: Jeff, I think that is why -- and I think it is the wisdom of the group that that is why we should create this process, whereby standards are vetted, discussed, implementation guides are produced and they are handed over to performance testing entity, checked and so on. So that if and when Internet based standards come up, those can go through the same process and those can become standards as well. We are not saying you can only have 2,231 standards and that is it.
MR. BLAIR: I am vigorously nodding my head for the folks on the Internet that can't see. I think that that is really what I was looking for. If we have a careful, consistent deliberative process with criteria, then it certainly can lead to definitive recommendations.
DR. YASNOFF: And it also will allow to some extent for thoughtful innovation. Clearly, what will happen over time is that transactions that are standardized in the year 2000 and 2005 may no longer be used, but if anyone used it, they would use it in the standard way.
DR. ZUBELDIA: I would add to that, that the SDO's have to be part and agree to that process. We have seen how it has taken about a year for the administrative transaction hosts to agree on what would be the data maintenance process for their transactions. So that can be a real effort.
There is one thing in which I am not sure what the recommendations should be. Bill mentioned that the government should create the implementation guides.
DR. YASNOFF: I didn't mean to imply that the government would create them, just that it would facilitate their creation.
DR. ZUBELDIA: Thank you for that clarification.
DR. YASNOFF: I did suggest that the government would do the conformance testing, but that could be contracted out to the private sector as well.
DR. ZUBELDIA: Or facilitate the conformance -- because there should be a requirement to do conformance testing. I don't think that we can ask for conformance testing of the implementation guides. We should go beyond that and ask for conformance testing of the implementations. So when somebody puts together a transaction, they can test it with a conformance lab of some sort.
DR. YASNOFF: Yes, but what the government can do that no one else can do is to say, this transaction implemented this way, approved by this conformance test is the standard; everyone must use it. No one else can do that except the government.
DR. COHN: Right, that is what the HIPAA regs are all about.
MR. BLAIR: It sounds to me as if there is a pretty good consensus that we have arrived at on item number one now, with the recommendations that fit that. Is that right?
DR. COHN: I have a question. I am actually excited by the process that we are describing in proposing, which feels to me very much like a HIPAA style process. In fact, in some ways, many of us who have been through the first part with the administrative and financial would think that this is a mirror of that around the clinical side.
Now, the question is though, do we want to begin -- what do we need to do with this? Do we want to begin to apply it and come up with some standards that we can then recommend to the Secretary as part of this process by a June set of recommendations to the NCVHS? In other words, what should we do about this, or at what level should we take it?
DR. YASNOFF: The wisest mentor I ever had gave me a wonderful piece of advice which is, don't do anything unless you're asked first. Let people know that you are available to do it, but don't do it until they ask you to, because they won't appreciate it. I think that applies in this case.
I think that by proposing this process, we have clearly identified these problems, we have listened to a lot of testimony. By proposing this process, we are essentially saying, Madam Secretary, here is the problem as we have identified it. We have thought this through. Here is a process which solves the problem. By the way, we are happy to deal with that process; if you would like us to, let us know. Rather than doing it without being asked. That would be my inclination.
I would rather let the process be considered and wait until the word comes back from the Secretary, yes, I would really like you to do this, because this is not going to be an easy process. It is a lot of work. I think that if we do it with a mandate from the Secretary, I think it will be easier to do. People will be more anxious to cooperate. Maybe there will be more resources available.
I think it will be very difficult to do without the mandate. For example, how would we deal with the issue of conformance testing?
MR. BLAIR: Other comments on Bill's comments?
MS. TRUDEL: If this were to be a mirror image of the way we have handled the HIPAA transactions up until now, part of the recommendation or part of what the Secretary might do with the recommendation would be to establish an internal implementation team similar to what we have done with the other transactions and code sets, which would take over a lot of the day to day development activity of that. That is one possibility.
Another thing to point out is, as Simon, you may have mentioned, the attachment model, where we began with six, and the idea was that after a great deal of work, we identified the most likely to be successful places to start.
If there is an analogy here where there are certain aspects of the patient record that could be identified to be addressed first, that might also be an appropriate part of the recommendation, without saying necessarily what the standard would be, or having this group offer to do it.
DR. COHN: And we could certainly ask for advice on that one from the SDOs.
DR. ZUBELDIA: I think that like Karen said, the model for administrative transactions in HIPAA is a very good model that could be used here. In the administrative transactions, the Secretary names a standard for claims.
There was a period of holy war on defining the standard for claims. You probably remember the models between NSF, A-37, UB-92. We ended up with four standards for claims, three of them using the A-37 and one using NCPAP. But still, that is a claim standard using the same standard, three different implementation guides of the A-37.
I think that there is probably a good way to prioritize the medical record standards to create a list similar to the administrative transactions, that is a functional list. It doesn't name a specific HL-7 message; it names functions to be made standards. Some of them, like for instance we had the eligibility, can only be done with X-12. For others, you may have competing ways to do it, or even more than one way to do it, and it is possible that more than one could become the standard. But I think that is something that, if this group creates a list of functional needs that need to be made standard, the SDOs and the task force and the Secretary would put together to take care of resolving how to do it.
MR. BLAIR: Any other observations or comments on Bill's suggestions?
DR. FITZMAURICE: This is a lot like the work that HL-7 does, so there is some precedent for the work and some places to point to. It is not starting with a clean slate, which is an advantage in this case. I don't know how much testing there is of the standards that HL-7 has put out for the specific functions, but I think that is a great way to go. They are very common functions -- drug ordering, lab test ordering, results reporting, for which we would say standards do exist. We could apply some criteria to those standards and say, all right, we have leading candidates; the Secretary should investigate it further and then adopt them, if she sees fit, if they meet criteria to her liking.
I mean to state it more strongly than I am stating it, but you know what I mean.
DR. ZUBELDIA: And we will see a situation -- for instance, you mentioned drug ordering, where NCPDP has a standard for prescriptions. They are going to have to decide which way we are going to go.
MR. BLAIR: Then do I hear that Bill's advice to us, that what we do is, we develop the process, and what we propose to the Secretary is, we have a process for the adoption of message format standards in a manner that promotes interoperability with things like implementation guides and things like that, and we are asking her to give us the authority to go forward with that process?
DR. FITZMAURICE: And the resources.
MR. BLAIR: And the resources to go forward. Is there a consensus here on that? Maybe, Margaret, if you are capturing that, --
AMATAYARUL: Yes.
MR. BLAIR: Did I also hear that there appears to be a consensus that that process will ultimately lead to the fourth level of adoption, which is complete usage over time? Is that also a consensus of the group?
DR. FITZMAURICE: I think the market will tell us that we are sitting in a place that the market has a place to go.
MR. BLAIR: It is leading to it, but I think the process indicated that we may have intermediate steps before we get there. So I think those are the main two points there.
Does this mean that we pretty much have consensus on item one?
DR. FITZMAURICE: I think so, once we see what it looks like when it is written down.
DR. ZUBELDIA: One and two.
MR. BLAIR: No, I thought we were about to discuss two.
DR. FYFFE: Let me put in some interference here. Is Clem going to agree with this?
MR. BLAIR: As soon as he gets to see it, we'll see.
DR. FYFFE: Okay, because we have to run it by him.
MR. BLAIR: Sure. And all the other members.
DR. FITZMAURICE: All the members of the work group.
DR. COHN: It has got to go through a lot of steps before it gets passed. Just to amplify what I am also hearing in relationship to this number one is that we are going to be listing functional areas or processes that we think are candidates and high priority items for this effort, so we'll be a little more specific. Though we'll stay above the issue of saying it is going to be a X, Y and Z SDO's standard at this point, right?
DR. FITZMAURICE: We might set up the list of functions and the process like the HIPAA processes that Karen and Bill and Kepa described, that can take it from there.
DR. COHN: Exactly.
DR. YASNOFF: Jeff, I don't think this is just message format standards. We are talking about standardizing transactions which includes the terminologies that are part of the content of the message.
MR. BLAIR: The only thing is, in terms of the terminologies, one of the pieces that it appeared everybody seemed to agree, the first item on the terminology section, which was the characteristics and attributes that would be criteria for choice on that. So I thought that was slightly -- maybe it would be correct in terms of the overall concept of what we want to do, and just a slightly different set of criteria for terminologies or something?
DR. YASNOFF: I think we need to have a separate discussion about terminology, but I just want to point out that we could have perfect, seamless interoperable message format standards with no information able to be transferred.
DR. COHN: I think that is the point of the implementation guides, if it specifies the content.
DR. YASNOFF: Right, exactly.
DR. COHN: There is an interesting issue which I don't think I have the answer to, but it needs to be investigated, which has to do with how, as you specify the content, how does that relate to underlying medical terminologies. That is I think an issue that we have been buffeting back and forth yesterday, and we kept running back and forth on, on the medical terminologies.
I don't think we need to address that right this second. Probably it is a January discussion as we begin to go through the recommendations again. At least, that is my view. It is not an immediately obvious answer, I don't think.
DR. YASNOFF: No, and sometimes when you try and create these transactions, you find that you don't have the terminology you need to send the information the way you want it, and so you have to invent a new terminology.
MR. BLAIR: I really think there are a lot of issues that those characteristics and attributes begin to address. I'm not ready to just immediately fold in terminologies.
DR. YASNOFF: I'm not suggesting that. I'm just making the point that in order for transactions to really work, they have to include not just the message format, but also content. That is the only point I'm making. I think we need to have -- I agree with Simon and you, too, -- we need to have a separate discussion of how we are going to deal with terminologies. I don't think it is going to be as neat and nice as the message format standards.
DR. ZUBELDIA: But I would see that as being part of the implementation guide. An implementation guide would say for this function right here, you use this terminology. In another place you use a different terminology.
MR. BLAIR: The only thing that I feel uncomfortable about is, it sounds like we are delegating to the SDO's the selection of terminologies. I think that is a major problem.
DR. YASNOFF: Yes. You are also opening up the possibility that -- although I don't think they would do this, that an SDO would say, in this field we want you to use this new terminology we just made up, which by the way is proprietary and you have to pay a huge license fee for.
DR. COHN: Once again, I really don't think we have the time or desire to solve this one today, except to note the issue. But going back to our HIPAA model, if we think about it, we for example had X-12 come up with implementation guides, and there is obviously a lot of content in those implementation guides. On the other hand, the Secretary and NCVHS and others reserve the right to specify important terminology areas, which is medical terminologies. That was not a decision by X-12 to implement ICD or others, but was made through another process.
So once again, there may be some wisdom in that process that we need to reflect on, but once again, it is probably not as clean here as it was for the administrative --
MR. BLAIR: Kepa, is that clarification that Simon made, do you feel comfortable with that?
DR. ZUBELDIA: Yes.
MR. BLAIR: So we have a consensus on that?
DR. ZUBELDIA: I have a comment on 1A. It says there, guiding principles for completing -- that bilateral agreements will not be necessary. I think bilateral agreements are still going to be required for contractual reasons. Privacy requires that partner agreement -- we somehow need to find another way to express that technique called mapping agreements will not be necessary. But bilateral agreements are still going to be necessary.
DR. YASNOFF: What is meant by that is, bilateral agreements that facilitate -- that compensate for lack of interoperability. Obviously, we don't want to prohibit people from making agreements about other things.
DR. ZUBELDIA: I know what we mean, and that is why I have been waiting for this for awhile, because when you get it fresh and you agree that bilateral agreements are no longer necessary, and you don't know what we are talking about, you will think, we are going to do this over the Internet, just like you buy from amazon.com.
MR. BLAIR: Could I propose a wording to turn that into a positive instead of a negative? That is, instead of saying bilateral agreements would not be necessary, what if we were to say that we would be promoting universal interoperability to reduce the need for individual bilateral agreements?
DR. YASNOFF: I think rather than referring to agreements, I think what you really want to reduce is the required work necessary to create an interface. That is really what you're after. People can make agreements all they want, but what we are trying to do -- in fact, you could stop, put a period after the sentence where you say message format standards that promote seamless unsupervised data exchange, period.
MR. BLAIR: Well, I feel comfortable. Do other folks feel like that is okay?
DR. COHN: I'm going to suggest that we move into two, only because of the time frame.
MR. BLAIR: Yes, let's do that.
DR. COHN: And see where we are on that particular recommendation.
MR. BLAIR: Are we ready to move to two now? Good. Margaret, maybe you could read that.
AMATAYARUL: I'm coming. Many testifiers have expressed a need for frameworks, architectures and models to help coordinate the interoperability among message format standards, as well as to help correlate medical terminologies to message format standards.
We said that recommendations from here should go into number one, but the issue goes elsewhere or be dropped. The recommendations are that the government should adopt guiding principles for PRMI message format standards that include the requirement for a framework for communications that separates information, content, definition from transmission format. This would achieve both functional interoperability. Messages can be transmitted between two systems and semantic interoperability, informational messages, can be used in an intelligent manner.
Then we added, the government should require message format and content standards for PMRI for all communications within and sent to or received from the government.
MR. BLAIR: That last piece wasn't a complete sentence. What was that? I got lost on it, what you just read to me.
AMATAYARUL: The government should require message format and content standards for PMRI for all communications within and sent to or received from the government.
MR. BLAIR: Oh, I see, okay.
AMATAYARUL: Then C is, the government should require that PMRI products it uses should incorporate standards for PMRI content, structure and architecture in a shared information model.
Then we also referenced for A, which relates to coordination by ANSI HISB or other body.
DR. COHN: Maybe if I could just start with a comment, and then I'll let others. As we fleshed out number one, number two seems unnecessarily technical, and I don't think adds anything to the discussion, at least as best as I can tell. That is my opinion on this one. Of course, I said that yesterday also, so you know my opinion.
Other comments?
AMATAYARUL: I would just mention, there was an awful lot of discussion about the need for a model, for many purposes. Specifically to identify gaps and overlaps. That may not be the best way to do that, but that was testimony that we heard. So obviously it is up to you whether you want to keep that in or not. It was an awful lot of discussion about this.
DR. COHN: I see under four where it says, part of the role of whatever group that we had asked to do this whole issue of data registry and promote coordination, had to do with, support the conferences and workshops to determine the best ways to converge reference information models from message formats, with the content of reference medical terminologies. So I agree with that.
The question is, what does this particular set of recommendations add to that particular recommendation?
Kepa, do you want to comment? I may not be fully understanding this particular piece.
DR. ZUBELDIA: In 2A it talks about framework for communications. If it is talking about telecommunications, framework for using the Internet, for instance, I can see how it adds to number one, because you have the data standards, and then how to transfer the standards, which is by itself another technical barrier to interoperability.
But I'm not sure that is what it is talking about.
MR. BLAIR: Is it possible to take -- Margaret, I guess I'm asking you, you pointed out that there was a lot of testimony on the need for models.
AMATAYARUL: Right.
MR. BLAIR: If we were to move that issue down, is that issue not sufficiently articulated in number four? Maybe if we enhanced that, then -- Simon's point was that he thought these other recommendations here addressed that issue.
AMATAYARUL: Number four --
MR. BLAIR: Is that what you are suggesting?
DR. COHN: Yes, exactly.
AMATAYARUL: Number four needs rework because of terms like confusion in the marketplace, limited implementation capability and things like that. We have got comments from Clem.
DR. YASNOFF: Simon, are you suggesting that we take the issue from two and move it to four and get rid of the verbiage that is in four that Clem objected to? Let me just say, if you are, I agree.
DR. COHN: Clem's comment on issue two is frameworks. This is a very vague subject. It gets totally confused with models, which is what I was commenting on. I do not hear it as a clear call from a testifier. I don't know what we can do about it anyway.
I think that models and frameworks and all this are important, but I don't think we are calling for frameworks. I think we are more trying to use them as a tool to help with coordination and all of this stuff. So I saw them as part of the recommendation, knowing that four as an issue needed to be wordsmithed. I think there is overall -- we heard from many testifiers that there was a feeling of the need for coordination as an additional tool to help with interoperability, et cetera, et cetera.
Coordinating models, understanding models, understanding frameworks and whatever, if there are not ways to coordinate them, is a very important thing, but it is a tool for coordination, it is not something in and of itself.
DR. YASNOFF: I agree with that. I would reiterate Clem's point, that people have been trying to develop these information models for many, many years, and it is a difficult problem, and I don't think that it is -- we can recommend that the government adopt a model, but it is not going to happen, because it is too difficult a problem.
So what we can recommend is that the government try to facilitate work on the development of models, because models help facilitate the development of standards and interoperability. I think if you want to say that, you could change the language in two, drop frameworks and architectures if you like, or if Clem really objects strongly.
I think that the recommendations in four relate to this issue more of models, but I'm not sure. But certainly the recommendations that are here in two really don't relate to this issue at all. They really relate to the issue in one.
MR. BLAIR: Simon, could I ask you to take the lead in leading us through these things, because they touch on some of the issues with respect to ANSI HISP. I recuse myself from discussing that.
DR. COHN: My view is that somehow, two and four need to be somehow melted together. First of all, my general feeling is that we've got a lot of models out there, and we've got a lot of frameworks. The issue is not developing yet additional frameworks, models, architectures, but figuring out how to coordinate what we have. That is one person's view. It may be that we lack the essential model or the essentially architecture or framework, but that would have to be proven to me.
My recommendation -- and we need to review this after we deal with four -- is to somehow -- the essential action piece needs to be somehow put together with four. Jeff has asked me to lead the discussion on four, just to review where we are. I think he feels there is some conflict of interest, which I understand and appreciate.
As we discussed this yesterday, there are really two pieces to this -- actually, probably three pieces. One is that there is an issue and a perceived need that we heard from many testifiers for increased coordination. Somehow, there is an issue of redundancy and some confusion and gaps, and some redundancy. We certainly heard that from people in the market pretty strongly, that sort of feel and how you put it together, depending on who it was that was testifying. That was really what I heard.
Now, if indeed we believe that that is the right description of the issue, then it appears that there is an opportunity to do something about it. So we divided it up into what it is that needs to be done, and then who should do it.
I think the key issue first of all to discuss is, what is it that needs to be done to help with this issue beyond that which we have described in one, because one obviously is doing some things in that area, but are there other things that need to be doe.
I think this recommendation -- Margaret, can you read the recommendation as opposed to trying to read the issue, since we know the issue needs to be reworked?
AMATAYARUL: The government should promote coordination among message format standards and medical terminologies by formally recognizing and providing appropriate subsidies to ANSI HISB for the following activities. One, development and maintenance of an open health care data registry based on the ISO 11179 standard for meta data, which would include the data elements from the major health care message format standards and information models. Two, support for conferences and workshops to determine the best way to converge reference information models for message formats with the content of reference medical terminologies. Designation as a national standard for PMRI message format standards and medical terminologies. Promote the evaluation of potential overlaps and development of standards needed to fill gaps. Responsibility for looking at consistency, redundancy, and looking for gaps.
DR. COHN: I had thought on the basis of a conversation we had yesterday, before we get into further comments, that we were knocking three out, because we didn't understand what three was.
DR. YASNOFF: And we can start looking for redundancies and find them in four and five.
MR. BLAIR: Just so I can follow, item three was what?
DR. COHN: Designation as an American national standard for PMRI message format standards and medical terminologies. I was also going to recommend -- once again, I want to take the HISB discussion out of the picture for a second, and just talk about the functions.
It appears to me -- my own personal recommendation would be that the work that has to do with the identification of gaps, redundancies and issues of consistency probably need to be reported both to SDO's, but also needs to come up probably back to this group, I would imagine, to the NCVHS, in terms of reports that then become recommended as various actions by HHS. So in a sense, if this is going to be happening, one would want to have the government informed of what is being discovered. So I think there is a loop there that we would recommend closing.
I should ask peoples' opinion. Is this something that ought to be happening? Is this a useful activity? Should this be done by someone?
DR. YASNOFF: Which activity are you asking about?
DR. COHN: What?
DR. YASNOFF: Which activity were you asking about?
DR. COHN: I was asking about them all, but we can go from one to another if you would like.
DR. YASNOFF: I think these are useful activities, but I don't know if ANSI HISB should be designated to do them.
DR. COHN: Let's keep the issues separate. The question is, are they useful activities, and then we can talk about who and how they ought to be done. So you think they are useful activities?
DR. YASNOFF: I think they are useful activities, and I think they should be done. We certainly heard a lot of testimony saying that people would like these things to be done. I'd be interested in hearing what other people have to say.
MS. TRUDEL: These activities are really consistent with the data maintenance activities on the administrative transaction side.
DR. ZUBELDIA: I agree, I think it is very important that it be done.
DR. COHN: Kathleen?
DR. FRAWLEY: Agree.
DR. COHN: So I think we are saying that at least I would judge that they be useful. Just to clarify for Karen, I think these are intended to include administrative and financial as well as any clinical standards, so it is trying to move them together. I think an emphasis on HIPAA standards would be very useful to start for something like this.
Bill, you were commenting that -- maybe we should ask, is there anything else here that we are missing before we start talking about who the candidates are for potentially doing this?
AMATAYARUL: Number five also had a recommendation regarding NCHISB and its role. So you might want to consider number five's recommendation as part of that list of things that this organization or NCHISB or whatever would do.
DR. COHN: Do you want to read the recommendation? It seems to me it is the same recommendation as in number four.
AMATAYARUL: We had, the government should formally recognize and subsidize an organization or NCHISB as the oversight organization where a collection or repository of standards activities is maintained and used to harmonize these activities. There is a note, and then, clinical SDOs should pay attention to this organization, clarify with ANSI the charter for NCHISB and report for next meeting. Benefits need to be clear so voluntary acceptance of the process.
DR. FITZMAURICE: Is the sense here that we would have ANSI or whatever organization report back to NCVHS, so NCVHS could make an adjustment and then make recommendations to the Secretary?
DR. COHN: You mean five or four?
DR. FITZMAURICE: Both, both of them together. Is there a difference between them?
DR. COHN: I don't like the wording of five, but I think the intent, at least from my view, closing the gap, is that the information discovered needed to be reported back either to NCVHS or another federal group. Probably NCVHS is the likely group to identify whatever recommendations need to find their way back up to the Secretary or other things, if indeed we're doing -- if we are managing the HIPAA implementations, this is valuable information to provide information for the Secretary. So yes.
DR. FITZMAURICE: I just wanted to have a sense that this wasn't going to go into the ether, that we were building a process of continued actionable items, continued advice at least on actionable items for the Secretary.
DR. COHN: Exactly. That was I think the intent. I am personally not comfortable with the wording in five. I don't see that that adds anything to the issues in four. I'm just talking about the recommendation itself. I'm not referring to the issue.
DR. YASNOFF: Maybe you could take the issue in five and put it in four.
DR. COHN: That may be a good answer. Let's just stay focused on the action items at this point. Five and four may come together as a new issue. But certainly B and five appears to be effectively already covered in four, as best I can tell, with the exception of formal recognition and subsidization as an oversight group, which I don't think is the mandate of our activities.
AMATAYARUL: That is also in four.
DR. COHN: No, this is formally recognizing and providing appropriate subsidies. I don't see that as -- I think the wording is different enough that it's different.
DR. YASNOFF: So why should ANSI HISB do this? Is there any other organization that can do it? I'm just looking for information.
DR. FITZMAURICE: Is another coordinating organization -- CPRI exists. I'm looking at what exists, HISB, CPRI.
DR. COHN: The government could do it.
DR. FITZMAURICE: The government could do it.
DR. COHN: Who else is a coordinating body that would be --
AMATAYARUL: Simon, yesterday you asked that we get the charter from ANSI for these boards. I didn't do that overnight, obviously, but it seems to me that as a former member of ANSI HISB, and there are a number of us here that were on that, I think ANSI's intent is for those boards to serve as coordinating bodies. That is not to say that you need to have that group do these things, but I do believe that their charter includes coordination of standards development organizations.
DR. YASNOFF: What about this new coordinating group? I am remembering the acronym, the TIHITA group?
DR. FITZMAURICE: That is an association of associations.
DR. YASNOFF: Is that another candidate to do this or not?
DR. FITZMAURICE: That is more a lobbying group. I think it is a C-6 rather than a C-3 organization.
DR. YASNOFF: What is the relation of ANSI to the government again, please? Someone remind me.
DR. FITZMAURICE: Officially they are linked to NIST. A, they are linked because they are the primary link between U.S. and international standards organizations. Secondly, they have a memorandum of understanding between NIST and ANSI that defines ANSI's role and gives them government sponsorship. They are not a government organization, they are a nonprofit organization.
DR. YASNOFF: But this is the organization that typically deals with standards issues for the government.
DR. FITZMAURICE: The government deals with standards issues for the government. I wouldn't say that --
DR. FYFFE: Are you talking about the history, where the Congress 50 years ago chartered ANSI?
DR. YASNOFF: The real question -- I'm trying to put on my procurement hat, my government procurement hat and say, well, if you're going to designate somebody, the first question is, is this the only person who can do this. And if not, then you better have some really good reasons why you're designating this group as opposed to someone else. So those are the questions I'm trying to get answered.
I don't have any bias one way or the other. I don't care if we designate them or not, but I think that if we want to designate them, we either have to say for these 17 reasons, these are the only people in the world who can really do a good job of this, or if that is not the case, for these 17 reasons, the other 47 groups who could do this really are no good because of X, Y and Z.
DR. COHN: We certainly don't have to make this decision right now. We probably need to do a little bit of an analysis. If we are going to recommend a specific group to do this activity, we had better have looked at the other options, and I can't think of any other very good options.
DR. YASNOFF: Let me ask another question. Do we need to recommend a specific group? If we want these things to be done, do we really care who does them? If we just want them to be done and done well, is it essentially -- unless there is a compelling reason to recommend a specific group, why be that specific. I'm the one who is always arguing for specificity, but when it comes to something like this, where there are competing groups who could do something, I think we may be getting ourselves into a sticky area.
AMATAYARUL: I just was looking at Clem's comments. He suggested that the only recommendation for identifying ANSI HISB may have come from the chair. But I would like to clarify that there were more people testifying than just the chair.
DR. FITZMAURICE: I would say that first of all, you need an organization that coordinates. HISB has shown that it does coordinate. In fact, it is chartered to coordinate among standards developing organizations, but in fact it is coordinated among users and other communities than just those who produce standard developing standards. In fact, there may be six or seven standard developing organizations, maybe another six to nine adjacent to that, and that would pretty well cover the health field. I may be short a couple.
Also, you have a national process to reach consensus. So you would expect that something that comes out of HISB would have been vetted among the people that it would affect, particularly the standards developing organizations, and some kinds of consensus reported out, or reporting out a lack of consensus.
So part of the job is to try to achieve consensus, and not simply say, here is what two or three people thought, and here is a good idea. It is part of a nationally and internationally recognized process. The American National Standards Institute in fact stamps or certifies organizations as following a process that will lead to American national standards, and when something gets the stamp of American National Standard, it does not duplicate another standard, and it has been deemed by the consensus process to be the one standard in that area.
Those are all desirable characteristics. Other organizations could convene wise groups of individuals or organizations, could undertake a system to find out what is going on in standards, and could be goal directed. They may or may not be in it for the long run. HISB may not be in it for the long run, but it does exist, and its purpose fits probably the most closely with what I see that we want from these activities.
MR. BLAIR: Can I say something in my defense here? Margaret just indicated that Clem said, and maybe you could read the comment, Margaret.
AMATAYARUL: Well, he says here, I don't recall hearing any discussion of some of the strongest recommendations, example, fund HISB as the coordinator, on committee, and do not recall hearing that recommendation from testimony, except perhaps from the chair of HISB.
MR. BLAIR: I did not create the first draft of those recommendations. Margaret came up with them. The action that I did take was, I did work on the wording, especially after the last ANSI HISB meeting, to reflect some of the specific activities last week when Bob Mayes proposed the funding for the data registry. There were other proposals.
So in order to reflect what was going on in ANSI HISB, I clarified wording, but I have not been asked by Peter Vagemann, my employer, who is the chair of ANSI HISB, to do any of these things. He hasn't even asked me what the status is on these things. He has just complete radio silence on this.
The only other thing that I would ask is, the only conversations that I have had and interactions that I have had have been with Margaret. I personally feel like that would be inappropriate for me to do that. So I would ask Margaret if you would reflect to the group your understanding of the role that I have played in this.
AMATAYARUL: Yes, Jeff, I have to concur with exactly what you said. That is really the reason why I mentioned that there were -- and I can't call up exactly who said it or exactly how many people, but I know there were more people than just Peter.
DR. ZUBELDIA: Jeff and Margaret, thank you for the clarification. I don't think it was necessary. I think I said this yesterday; the law itself specifies some conditions for adopting a standard. One of them is that the standard be developed by an accredited standards committee of ANSI. ANSI has a group to coordinate the development of health care standards for HISB.
So I think it is natural that we would recommend that HISB does the coordination, since my understanding is that they are chartered with that task. Since the law requires us to adopt standards passed by ASC's, it would be natural that HISB does the coordination of the standards we are going to recommend.
DR. COHN: Other comments? Let me make a comment or two, and Jeff and Margaret, thank you for the clarification. I agree with Kepa; I don't think it was necessary.
I think that once again, going back to our initial view, which is that there are two issues, one, does this thing need to be done and then who should do it, I'm going to suggest that the recommendation be reformatted to remove in the top item, specifically the reference to HISB and specifically the issue around formally recognizing HISB for the following activities, but that we identify all of these activities that need to be done, which we recommend that the government needs to subsidize.
Then I think at the bottom of the recommendation after we have listed all the activities that need to be done, then I think there is a separate recommendation that says that after careful consideration, we recommend X group doing this, which I think is not the same thing as formally recognizing, but it certainly is providing subsidies.
The government needs to fund this activity, needs to support it. I think that you having them be separated like this may provide a little more clarity as well as a little more ease certainly for our discussions to the NCVHS.
Margaret, I would ask you to check the charter, which we have already identified, as well as, we would ask you to do any background research that seems appropriate to identify any other candidate groups that may be appropriate for this activity, so that in January we can revisit this, see if there are any groups that have not been immediately obvious to us at this point.
Is that a reasonable set of action items for everybody?
DR. FITZMAURICE: I think what that does is put emphasis where it should be. That is, the task should be done. These are public goods, they have many good public aspects, and should be subsidized by the government, and should be done by the best place they can be done.
DR. COHN: Exactly. So are we okay with four at this point? I think we have agreed that five should be somehow put together with four.
It is now 10:30, I believe, so is there anything -- yes, Jeff, do you want to adjourn the --
MR. BLAIR: Simon, thank you very much.
DR. FYFFE: One question. When is our next meeting for the conference call?
MR. BLAIR: There is a conference call for January 10. Margaret made a suggestion to me early on, and you folks just give us some feeling for whether you would like us to do this.
Right now, the plan is calling for a first draft to be pulled together and distributed by January 4, so that you could read it and begin to share comments on January 10. Now at the moment, we have a two-hour conference call set up to review that first draft.
Let me just discuss that one first, if I may. I was thinking two hours, because I know how difficult it is for people to break out more time, especially on a conference call to go through a document. However, based on these last couple of days, what is the thinking of the work group? Should we have a conference call that lasts longer than that?
DR. FYFFE: Two hours.
MR. BLAIR: Two hours? People agree?
DR. FYFFE: Yes.
DR. COHN: Yes.
MR. BLAIR: And you would have the document at least four or five days before --
DR. FYFFE: Please.
MR. BLAIR: -- so that you would have a chance to read it. Now, in addition --
DR. COHN: Bill has a question.
MR. BLAIR: Yes, Bill?
DR. YASNOFF: I certainly agree that no conference call should be more than two hours. But I think we should schedule a second conference call as a backup, and the incentive to getting through in two hours is then you cancel the second call. But I think based on the discussions we have had, there are going to be quite a few changes in this next draft. I think it deserves the time needed to go through the draft carefully. Otherwise, we are going to end up with very extended and perhaps unproductive discussions further on down the line in the process.
MR. BLAIR: Okay. If we do that, may I suggest for the benefit of those who have to write this report and have it ready for us to review on the 31st, that if we do have a second call, that it be within a day or two after the 10th? And if you wanted to pick a date -- Margaret, is this okay with you, a second call? I don't know your schedule.
AMATAYARUL: Yes.
(Discussion off the record regarding meeting dates.)
MR. BLAIR: So we have January 10 from 1 o'clock to 3 o'clock Eastern Standard Time, where we have a 99 percent chance of completing it. But for the one percent, then we have our backup of Thursday, the 13th of January, beginning at 12 noon Eastern Standard Time, scheduled for two hours, is this correct?
AMATAYARUL: Yes.
MR. BLAIR: Now, Margaret made a suggestion to me early this morning --
DR. FYFFE: Excuse me, Jeff. Looking on my calendar, do we also have a meeting scheduled Monday, January 31 and Tuesday, February 1?
MR. BLAIR: That is absolutely correct, yes.
DR. FYFFE: That is here?
MR. BLAIR: That is here, in person.
DR. FYFFE: Thank you.
MR. BLAIR: Yes. Matter of fact, one of the things that Jackie distributed to you yesterday morning, you may want to flip it out to make sure, this might be a good time to review it, is the outline for our major dates and activities. Do you see that as a one-pager?
Let me articulate it.
DR. FYFFE: Is it dated December 9, detailed schedule to develop recommendations?
MR. BLAIR: That is correct.
DR. FYFFE: It is numbered, items one through seven.
MR. BLAIR: Yes.
DR. FYFFE: Yes, we did get that.
MR. BLAIR: Okay. If you look at that, what you are seeing is that we are crafting it so that by the time we get to the end of February when we are reviewing this for the full committee, we will have -- that will be our third draft. That is not our final draft, but we wanted to get as far as possible so that we could get as rich a critique and guidance from the full committee by that time. So we have been driving on an aggressive schedule to do as much by that deadline.
So the first draft would be what we would be reviewing January 10 and 13. The updates to that would then be reviewed on January 31 and 1st. That would be the second draft that is reviewed on January 31 and February 1. Then we would make modifications to that, which would become the third draft, which would be reviewed with the full committee on February 23 and 24th. Marjorie, are you here?
DR. GREENBERG: Yes, I am.
MR. BLAIR: Is that the correct dates for the full committee meeting?
DR. GREENBERG: Yes.
MR. BLAIR: Then based on that, there would be additional changes. Simon has suggested that we might have an additional day or so, depending on where we are and how many changes there are and what are the things we want to do either in late March or early April.
DR. GREENBERG: Excuse me, there was some question, but it is the 23rd and the 24th.
MR. BLAIR: Should I repeat these last comments here?
DR. FYFFE: Please.
MR. BLAIR: Simon had suggested -- I think it is a very good idea -- for us to -- and we don't have to agree on the date at this time, but as we go along we'll have a firmer idea of the types of things that we might have to modify, change or update after that full committee review, and to meet back either in late March or early April, not only for that, but for other full subcommittee activities.
DR. YASNOFF: Don't you think that is too long to wait after the 23rd and 24th, in terms of dealing with -- I think we should anticipate that there will be major issues that we need to deal with. Maybe not, but we can always cancel the meeting.
DR. COHN: Are you talking about the conference call?
MR. BLAIR: This is full meeting?
DR. YASNOFF: A full meeting. We certainly should have something fairly soon after the NCVHS review, either a conference call or a meeting. I think that if there are major issues, having a meeting is more effective than having a conference call and dealing with those.
MR. BLAIR: What would you suggest as a time frame.
DR. YASNOFF: Soon after. Sooner than the end of March.
MR. BLAIR: Sooner than the end of March.
DR. YASNOFF: In other words, unless you, Jeff, want to take the responsibility for responding to the comments and producing another draft and circulating it. But I think if there are major issues, and I think it would be better to assume that there are --
MR. BLAIR: I was assuming that there would be, and I was assuming that in order for an update to be done, that there might need to be a couple of weeks to do another draft and then get it out for people to review. So I was figuring that was probably going to be about three weeks before we can meet again.
DR. YASNOFF: I guess this is your choice, if you want to take the responsibility yourself, or if you want to have consultation from the committee.
DR. COHN: Jeff, if I can make a comment, I think the process we have been going through, which has been a combination of some excellent staff support and conference calls leading up to the development of another draft, has probably so far been a very good process. I don't think that it serves us to all get together and spend our time with very marked-up versions of things that haven't been put together into the next draft. So I just recommend, observe that the current process seems to be working pretty well, I think that we ought to be replicating that process after the February meeting, which I think is, Jeff, what you had been describing. So I don't think a meeting a week or two after the NCVHS meeting is going to be particularly useful.
DR. YASNOFF: Aren't you assuming that the comments are not going to be major?
DR. COHN: No, I am actually expecting that the comments are going to be major. That is why I expect we're probably going to do a conference call.
DR. YASNOFF: So you would like to do a conference call soon after?
DR. COHN: Yes, conference call, draft discussion.
DR. YASNOFF: So maybe a conference call the next week, and then leave several weeks for a new draft?
DR. COHN: Exactly.
DR. YASNOFF: Oh, fine. So maybe a conference call the week of March 6, which actually leaves a week in between. How does that sound?
DR. COHN: Sounds good. Since you're mentioning that, should we just slot a time in early? Is the pleasure 1 p.m. Eastern time, which day?
(Discussion off the record regarding meeting dates.)
MR. BLAIR: I don't want to lose one thought that Margaret had suggested early this morning. I'm looking for the feelings of the work group on this suggestion. That is that the changes that had been made during these two days be distributed not in the first draft of the report, but just in terms of the things Margaret has captured here.
DR. FITZMAURICE: Jeff, if you want to, I could make a copy of it and take it to a computer and get a paper copy of what we have so far, before we adjourn.
MR. BLAIR: I think she was looking for something a little different, because we wanted to make sure that we had captured everything in the right perspective. Also, she was suggesting that she distribute a version of this next Wednesday afternoon. Margaret, did you want to clarify or elaborate on that?
AMATAYARUL: Yes. I think it would be helpful for me as we prepare to write the narrative that we make sure that we have at least fairly accurately captured the is and recommendations. I'd like to be able to just send back the table to you via email. You can send any comments back that you want. That would be helpful for me. That would allow me to then better incorporate those into the narrative.
MR. BLAIR: Would this be helpful to the work group? Okay. Let me adjourn the CPR work group, unless there are any last-minute things or anything else. This has been a very arduous, long, but I think extremely productive day and a half. Thank you for everybody that took the time to be here, and for all of the input and constructive ideas. We are just beginning this process. I really appreciate the input on the start. Simon?
DR. COHN: Actually, Jeff, I hope we are somewhere in the middle of the process. At least, that would be my hope.
What we are going to do is to adjourn for about 10 minutes, and then we will start off as the full subcommittee.
(Brief recess.)
DR. COHN: This is Dr. Simon Cohn. I am chair of the Subcommittee on Standards and Security. I think those of you who have been on the Internet are aware that we have spent the last day and a half meeting as the Work Group on Computer-Based Patient Records.
The purpose of the next hour, hour and 15 minutes is to deal with business related to the overall subcommittee. I think we probably can just go around and do quick introductions. I think pretty much the same people are in the room, but anyway.
(Whereupon, introductions were made.)
DR. COHN: There are a couple of issues for us to talk about. We're going to start with a brief update on the status with the HIPAA regulations, and then talk for a second about where we are with claims attachments, knowing that was initially going to be part of the discussion today. Then we are going to talk about and get some input on the report to Congress. As you know, every year we are mandated to prepare a report to Congress on the status of HIPAA implementation, and we are just beginning to write that. We expect to have it for the NCVHS in February. So this is the occasion to get input from the subcommittee on issues that should be addressed in that report. Then finally, a review of the work plan, specifically in relationship to priorities for hearings in the year 2000.
Is there anything else that we need to be addressing and talking about, other issues?
Bill, would you like to give a brief update on currently what is happening?
DR. YASNOFF: I'll give you a brief update on the privacy regulation, although I'm sure you don't need that, since you have been around recently, and then Karen will give us an update on the other standards.
The privacy regulation came out as a HIPAA standard, because Congress did not pass a law. We published an MRPM on November 3 of this year, with a 60-day comment period to end January 3, year 2000.
I'm not sure any of the computers will be working yet by the end of that comment period after Y2K. We have received and are seriously considering a significant amount of input about extending the comment period for that privacy regulation. I expect a decision very soon, about whether or not we will do that. I'll send out a message to that effect on the listserve on the website, and it will be published in the Federal Register.
The only other thing I might add is that the not totally unexpected, but unplanned for and unfunded requirement of resources to put the privacy reg together and to monitor its progress has caused us to lose a few resources in dealing with the other regulations. The claims attachments reg which we had expected to have out by now for discussion at this meeting is not out yet, is in the final stage of clearance by the Department. The only reason it is being held up is not because there is anything wrong with it; it is just that people have been so focused on the privacy thing, they haven't had time to read it and analyze it and clear it. I expect that to happen very shortly as well.
Then it has to go to OMB and so on, so I wouldn't expect that to be published until very early next year at this point.
Karen, do you want to fill them in on the others?
MS. TRUDEL: The remaining regulations that we are working on are the transactions and code sets, which we are giving our top priority. There are a few remaining issues to be resolved. We had obviously hoped to have all of the final rules published by this time. Clearly December is not going to happen. We would very much like to move these through the clearance processes as quickly as possible, and would hope that sometime in late January or early February, we could begin to see some of these coming out.
We are also very close to the end of the internal team review process on the final rule for security. We did de-couple electronic signature standards from the security standards, because there were a number of technical issues and changes that had occurred since the time that we published the proposed rule, and some of the comments and also NIST asked us to take an additional look at what we were proposing. Rather than hold up the security rules as well we have simply split them in half, and we are proceeding on the security rule right now.
The provider identifier rule and the employer identifier are also drafted. The employer ID is ready to go through as soon as the transaction rule goes through. They will probably be hand in hand. The provider identifier is being looked at again by us in HCFA from the HCFA perspective, because a number of the folks who will be involved in implementing that are beginning to turn their attention from Y2K and are making sure that they have a good comfort feeling for what is being proposed.
There was a presentation on that to be at the HCFA executive council this week. We expect that that will begin to move fairly soon also.
The health plan identifier, we still have some very basic philosophical issues that we have not been able to resolve at this point. I'm not sure whether this group might be interested in becoming involved in or not.
DR. COHN: Is that something additional that is going to be required?
MS. TRUDEL: How we structure the requests for input and how we structure the models that we set out in the regulation. Really, the basic issues is to what extent is this simply an identifier to be included in electronic transactions, and to what extent can and should this be used to facilitate electronic routing of transactions.
DR. COHN: I think I would just comment on that. I think from the NCVHS view, we are very involved and concerned with this issue. I think the issues of identification of plans is an important issue, and so we would extend our offer to help in any way we can with whatever input is required.
DR. FYFFE: For the health plan ID, has there been any thought given to publishing in the Federal Register the intent to issue a proposed rule?
DR. SCANLON: A preliminary rather than an MPRM?
DR. FYFFE: Correct.
MS. TRUDEL: Actually, we had not thought about that, but that is a very good idea. I think we need to take that back to the HDSC and talk that through.
DR. ZUBELDIA: For the provider identifier, have you thought of splitting the two functions, like you are splitting security into security and signatures, splitting provider identifier into identifier and routing, and have two separate MPRMs, one for identifier and maybe another one for routing? Or another one for a new identifier that would be used for routing. I'm sorry, not provider, health plan or health plan identifier.
DR. COHN: It's a health plan issue. Are you talking about the health plan identifier?
DR. ZUBELDIA: Health plan identifier, I'm sorry.
MS. TRUDEL: No, actually we had not thought about that, either. That is another possibility. Thank you.
DR. COHN: Other comments or questions regarding the current status in the ongoing issues here?
DR. FYFFE: One question. What is the overall status of the individual identification number, can you remind me where that stands in the scheme of things?
DR. COHN: It's still on hold. The Congress renewed its prohibition on our spending any money on coming out with a final standard for that until they pass a law that approves a standard. The Administration is still holding to the position that we can't really work on it or even talk to people about it until the privacy protections are in place, because it gets all mixed up together and people can't talk rationally about it. So it is on hold until further notice.
DR. ZUBELDIA: When do they expect the digital signature MPRM to evolve or to come out?
MS. TRUDEL: I'm not sure that will be a proposed rule. That was part of the proposed rule for security. I think what the team wants to do is to simply take a little bit of time and see if there is anything that they want to change about the direction that they are going in.
It is not a question of back to the drawing board; it is just a question of, let's be sure that we are saying the right thing. So I think unless there is some drastic change in position, we are talking about a final rule being issued. I don't have any sense of when that would be, though.
DR. ZUBELDIA: Final rule for both security and signature provided them?
MS. TRUDEL: No, there would be two final rules. We had one proposed and we'll split that off and publish two finals.
DR. COHN: And presumably in the same time frame as the security rule?
MS. TRUDEL: Probably not.
DR. COHN: So the expectation is that it would be somewhat delayed for secondary review?
MS. TRUDEL: Yes.
DR. COHN: Now for our discussion for HIPAA status implementation, Jim, do you want to talk a little bit about that?
DR. SCANLON: Yes, let me start. To remind everyone, you will recall that HIPAA itself included among other changes to the NCVHS in membership and scope, it included a provision that the NCVHS would -- and I'll read it literally to you, it is a short section, basically would provide an annul report to Congress on the implementation of HIPAA. Not later than one year after the date of enactment of HIPAA, and annually thereafter, the committee shall submit to the Congress and make public a report regarding the implementation of Part C of the administration simplification requirements.
The report is to address at least the following subjects to the extent that the committee determines is appropriate. Before I read these, you are now getting at your place last year's report and transmittal letter to Congress.
DR. FYFFE: Let me just point out -- and I remember, we had talked about this. This letter as it appears on the admin sim website has a date, but this one doesn't, so the date of this was April?
DR. SCANLON: I think it was after the June meeting of the NCVHS. I think it was probably late June.
DR. COHN: If you remember, because of the need for additional views, even though this was presented with the March meeting last year, it wasn't finally passed by the NCVHS for another session in June.
DR. FYFFE: So this handout -- the report has a date of April 21.
DR. SCANLON: It is the final report. It is still the same report. It should say June.
The report again as Simon described the process last year, the proposed report was discussed after the February meeting. there were some issues relating to dissenting views or additional views, so the report was not approved at that meeting. The process for dealing with additional views as well as edits to the report were later considered at the June meeting, and then it was transmitted to Congress, and posted on the website.
Let me briefly -- in the statute itself, there are several things that the committee has asked to look at, to the extent that the committee has determined as appropriate, but the committee can highlight anything or point out any issues related to implementation that it wants. But just so we know what the statutory language is.
The report shall report on the following subjects, to the extent that the committee determines appropriate. First, the extent to which persons are required to comply with these provisions are cooperating and implementing the standards adopted under such part. Secondly, the extent to which such entities are meeting the security standards adopted under such part, and the types of penalties assessed for noncompliance.
These are the sorts of things you would look at after you have actually adopted the standard and it is in effect. So these are not things that can only be reported on at this point in the adoption process, because the standards are not yet in effect.
When the federal government and state governments are receiving information of sufficient quality to meet their responsibilities under this part -- and again this relates probably more to implementation itself -- any problems that exist with respect to implementation, and the extent to which timetables under such part are being met.
So the first three of these are really related more to the point at which we actually have issued the final standards, and we have entered that ramp-up period, the 24-month implementation cycle, and then where people are actually required to implement the standards, we can monitor how it is going in, whether penalties are being assessed and so forth.
So the committee has so far provided two reports. The first year of implementation, there was a report to Congress that obviously dealt more with the process of consultation, how the various requirements were met, and the progress being made in terms of consultation. I don't think at that point any of the MPRMs had been issued.
Last year, there was a lot of success in getting the proposed standards published. So the report that was filed last year and you have before you basically dealt with the requirements of the law itself, the process that was being used to develop the proposed standards, the process for adoption, and the stages at which the various proposed rules were, including privacy and including a reference to the ultimate clinical data standards as well.
There were some potential issues that were identified last year in the report. So this year, we have laid the background in terms of two prior reports. So in that sense the committee has a relatively free hand at what it wants to highlight. So the report that you have before you was the June report. You may want to look at the executive summary, the detailed outline, and then the detail with the report itself. And in terms of what the committee may want to retain from the old report, update or even throw out and include new areas. You may want to look at the detailed outline to see what areas we might want to highlight or not.
Then in terms of the factual situation, the progress reports and so on, we can pull together the basic information in terms of where all of the proposed rules are, including privacy, including now the CPR standards as well. I think we now have to start reporting on those. Certainly any issues that the committee wants to identify as potential implementation issues, we can highlight as well.
There were some issues in the table of contents for last year that I think the full committee wanted to highlight. For example, the need for anti-discrimination law. I think the full committee last year wanted to again make a point and underscore the need for privacy protections and security. There was some discussion there of the unique identifier and its relation to privacy. So the committee has a more or less free hand in terms of this year's report, in terms of what it might want to highlight.
The other point I would make is that we provided a lot of detail in the first two reports on the process itself, the requirements of the law and the process that HHS and the committee were using. We reported virtually every activity that the committee undertook relating to the standards. We may want to think about streamlining at this point. I think for most people, the groundwork is laid, there is a lot of material on the websites and in the literature and in the trade news now, so it could be that we could dispense with a lot of the background with references and maybe just focus on the progress and so on.
I'd be happy to answer general question. But you may want to look at the outline as a way of what we would like the report for 2000 to look like.
DR. COHN: Shall we start with general questions, and then we can make comments about the outline, and also how we want to proceed to get this thing done by February? General comments? No?
I think I want to start out by making a comment about focuses for this coming year. I've been thinking about this, and I usually set the tone by making a couple of observations of things that I think probably need to be emphasized, or at least need to be expanded.
I have reviewed the document. This is not something you can cut and paste and just change the dates on. There are a lot of things that have happened and some changes. But I am at this point of implementation particularly concerned about issues around progress to date, and the implementation plan and communication strategy. I think as we begin to move into next year, that will be really a major issue.
I have already brought this up at the executive committee, but I do want to make sure that HHS is appropriately staffed, supported by Congress, and that the right resources are being deployed in the implementation.
It appears to me there are really two areas that are particularly dependent on HHS performance. One of them has to do with the identifier issues, since we know that HHS is responsible for maintaining the providers. So I think we need to both ask HHS and have reflected in this report the status and the adequacy we feel of that implementation, as well as, if there need to be additional resources, we need to couch that probably in some appropriate jargon.
The other piece is, at least as I understand the notices of proposed rules and the future process, the way the updating will occur is through effectively an MPRM process, generally. There will be updating, there will be notices of proposed rules that come out every year with changes, updates, expansion to the standards. Then HHS needs to review all of that, produce a new rule and get it out in a timely fashion.
I think that there is once again an issue of making sure there is adequate resources, and that they are actually able to do that, because if there are problems with either of these processes, we will not be successful in our implementation and ongoing support of HIPAA.
Those are just two initial comments in relationship to that. Do people have comments about that, or other thoughts?
DR. SCANLON: Just support for your comments.
DR. GREENBERG: You could probably identify other areas as well, like enforcement, that will fall upon the department. Bill or Karen may have others, but clearly you don't just get the final rule out the door and go to Y3K.
DR. BRATHWAITE: I might say, Simon, that there are several different mechanisms that we can use to update regulations, and for regulations which have already gone through some public comment process as a change in the implementation guides would for example. We may be able to get permission to use a different mechanism which would take less time and less resources than the MPRM comment and final rule process. We are exploring our options in that area. That may be helpful.
You should also know, for those of you who don't, that we have -- our enforcement team has been put together and is starting to meet to talk about putting out an MPRM which will cover enforcement for all of the HIPAA standards. I don't know at this point how long it is going to take to come up with an MPRM on enforcement, but we hope to have it out sometime next year, in time to do the comment and final rule, so everybody has lots of warning before any of the standards must be complied with, what the enforcement procedures and mechanisms will be.
At the moment, we have for the civil penalty enforcement, we've got our civil rights office, that is going to be looking at enforcing that, and we have to find the resources to help them do that. They have regional offices and so on, and this is a civil rights issue, so they are ideal amongst HHS' arm anyway for enforcing those issues. Of course, criminal issues by definition will be handled by the Department of Justice and the FBI, so we have them involved in these enforcement teams as well. So that will go forward. Once we figure out what that ought to look like, then we will be able to put the appropriate amounts to support that enforcement in the budget.
DR. SCANLON: Simon, it wouldn't hurt for the committee to begin to -- the committee can emphasize the areas it wants, but the idea of resources for implementation, it wouldn't hurt for the committee to go on record with sufficient attention to the resource issue than would be paid otherwise, that we ultimately are able to educate the community as well, or pull all the standards together and assure implementation and work effectively within the industry.
So in terms of concerns or potential issues about implementation, certainly the committee would want to think about that.
The other point I would make is, now we are getting to the point where we can actually see how the standards all would relate to each other and what the potential impact and inter-relationships are. Sometimes it is bringing up issues of what exactly is the relationship between A and B. So again, I think for everyone involved, it is a little easier now to see how the standards that have already been issued, along with the privacy proposed rule as well as the security rules, and potentially work on the clinical recommendations related to clinical data standards, I think it is a little easier for people to begin to see the overall potential, and how these relate to each other.
DR. FYFFE: The civil rights is part of HHS. What is the formal name?
DR. SCANLON: Office for Civil Rights.
DR. FYFFE: Office for Civil Rights. When you said an MPRM, does that relate to Title 2 of HIPAA, or would that also relate to Title 1 of HIPAA, which is the portability --
DR. SCANLON: I was only talking about the enforcement for the standards under administrative simplification.
DR. FYFFE: Which would also therefore include the enforcement of the privacy --
DR. SCANLON: Yes.
DR. FYFFE: Thank you.
DR. SCANLON: As Bill said, they have the apparatus already. That is the sort of office they are. They investigate, they have relationships with providers and so on, and they have a regional structure. So they are probably the closest capability we have in HHS to what is required here, and there is a certain amount of conceptual appeal in terms of civil rights, certainly for the privacy side of all of this.
DR. COHN: And obviously, we need to feature the privacy MPRM as a piece of the whole thing. I think the comments I was making were directed at an expanded -- not just progress to date, but a look at what is going to be required to make sure we are successful in what looks like a year where formal implementation is going to begin. That was what I was thinking about. The comments i was making were a bit of an expansion of that section. I don't know if we make that the -- I'm sure that is not the only thing we say here, but that is a piece.
Now, as we were beginning to work on this, what we were trying to do was to get the input from everyone to see what sort of flavors might be added in this, or if there are issues you want to make sure get reflected in the annual report. So we recognize that we didn't give this to you a couple of weeks in advance, but if you have any thoughts, this is a very good time to begin to bring them up, since Jim Scanlon has taken the responsibility for writing them.
DR. ZUBELDIA: I would say that the industry is taking a broad stance in terms of compliance verification. The INAC compliance verification system is up and running. It is being used by a few companies in a test model, but it looks like it has become an important part of compliance that has to be demonstrated before you can even think of enforcement. So I think that has been progress on the industry's side.
DR. SCANLON: We have had several requests for a process within HHS to deem or certify organizations that might then go around verifying compliance, and something like the NCQA does for HMOs or something like that.
We hadn't discussed anything along those lines. We don't have any funding for this thing, period. So we hadn't really thought about doing anything along those lines, although we have had some requests for that.
It seems to me at this point at least that the industry seems to be stepping up to the plate and coming up with voluntary compliance verification methods, certification methods. I'm not sure that is all bad.
DR. ZUBELDIA: Yes, and that is a very difficult task in security. For the standard transactions, it is relatively easy to see whether it complies or not. A computer can tell you that. But for security, it is a very difficult process. But the industry is picking up. There are some initiatives that are very actively working on that.
DR. COHN: Kepa, just to generalize this one, are you suggesting that we include in the contents of this report something that talks about the private sector contribution to implementations?
DR. ZUBELDIA: Yes.
DR. COHN: I don't see it here, and I think it would be a very nice additional section.
DR. GREENBERG: I wonder whether it would be a good idea at the January 31 or February 1 subcommittee meeting to hear from the private sector what is going on specifically in relationship to compliance, to hear from e-net, so that we have on the record some discussion or testimony.
DR. COHN: For the implementation of the report?
DR. GREENBERG: Yes, for the report, unless you want to informally gather that through your membership.
DR. COHN: We'll put that down. My only concern with all of this is, I hate to have implementation hearings before we have implementation.
DR. GREENBERG: I wasn't talking about the implementation hearings yet.
DR. COHN: You are saying something about approaches --
DR. SCANLON: You mean a compliance model?
DR. ZUBELDIA: The implementation guides for the transactions are final, unless there is something dramatic that happens during the final rule. They have been final since June. That is why ENAC has put together a compliance verification system.
Then there is a group led by Johns Hopkins University and SMS working on security compliance. I think it would be interesting to hear what they are saying.
DR. COHN: Other comments about that?
DR. GREENBERG: It would give some more visibility to these activities also.
DR. COHN: I think the only question -- we can reflect on this a little later -- is whether we put the -- that may be fitting well with enforcement, and it may be something we may want to do a little later on in the year, but we have to reflect on our January time frame, and whether or not this is critical.
The question I would ask is, are hearings like that useful for the development of the implementation report, or would they be better served as part of a general hearing, where we investigate the enforcement issues?
DR. ZUBELDIA: As far as reflecting the status of implementation, I think it is useful to reflect the fact that the industry is supporting the implementation with these private industry activities to help implement.
DR. SCANLON: I think it is important to have that in our report, even if we don't have a hearing for whatever reason. But it is a good idea to promote it and make sure people understand that that is what is going on, and the way industry is approaching it, in lieu of our having some direct involvement.
DR. COHN: Other ideas, issues, thoughts on this? Let's just talk for a second about the approach then to going from where we are now, which is last year's report and some comments to having something completed -- this sounds like a discussion that we had just a couple of hours ago around the clinical data standards report. This is hopefully not quite so difficult.
I think our intent on this report is to have it completed for the NCVHS meeting in February, which is the time that this stuff should come out. It should be at the beginning of the year.
Now, to do that --
DR. FYFFE: The draft in February? Do you mean completed?
DR. COHN: For the implementation report? I think that we would like to -- actually, that is a good question. Everything by definition when it comes to the NCVHS is draft until they approve it.
DR. GREENBERG: You would have wanted to vet the draft and then take it to the committee.
DR. FYFFE: I might have not been paying close enough attention, but if we are talking about hearings or information gathering in March, does that go in the fourth report or the third report?
DR. COHN: No, what Marjorie was suggesting is that we invite for a mini-hearing at the end of January, beginning of February when we were going to meet already, to have some presentations around conformance testing, around ENAC and the security compliance issues. She was not taking about March. I was bringing up the issue of, should we put it then as an actual information hearing activity or later on into the spring, in the back of my mind worrying about how much time the clinical data standards discussions are going to take. That was what was going on. But it needs to be reflected even if we don't have hearings on it. It may be an occasion for a session to hear from these people on conformance testing.
What I was moaning about was, we want to have what we think is a final draft for the NCVHS for their February meeting, that we have passed as a subcommittee, knowing that there are likely to be some changes from the NCVHS. To me, that means that we need to take some time in our January-February 1 meeting to go over this, and we'll have to have another meeting like this, except at which point everybody will have had a copy of it, and we'll go through it and make whatever changes we will need to make on it, and hopefully pass it.
Now, the question I have for everybody is, do we need to have a conference call at some point with a rough draft to discus it prior to that meeting?
DR. GREENBERG: Has it been determined how the report is going to be produced?
DR. SCANLON: I will be the editor. I will be the coordinating point. I think it is probably easiest for me, simply because I can do the part about where everything stands. I think what we can do is streamline that early part of the report. We can actually begin working on the update of what has actually happened and what are the requirements immediately, and then the important point would be what concerns the committee may want to raise, looking ahead to the issues that the committee will be doing in the year ahead, or things like that. They are probably somewhat different than the ones last year at those hearings.
DR. GREENBERG: I guess the report relates to the implementation of all the administrative and financial transactions. So I assume we would put something in about it, since so much has been done in the past year from the point of view of information gathering, et cetera, on the PMRI part?
DR. SCANLON: Oh, yes. I would view that as related, strictly a section. I guess Section C is what we are reporting on. Last year, I don't think we handed them a forecast that we would be focusing on this issue in the year ahead. I don't think we said much more than that.
DR. GREENBERG: Yes, a letter was sent to the Secretary, an interim letter.
DR. COHN: I would abstract significantly from that letter that we already sent to the Secretary. My view of this document is that it is an annual report on HIPAA implementation, but if I were not a member of the committee and were not truly familiar with the various activities of the committee, I would almost think that this was an annual report of the committee. Indeed, it merges sort of closely at times.
DR. SCANLON: The activities of the committee.
DR. COHN: Well, it merges pretty closely in some areas.
DR. SCANLON: There is a lot of what the committee did in there. You may or may not -- that is what people wanted last year. You may want less of that. We may be able to refer people to various websites and just focus on --
DR. GREENBERG: The population aspects of the work, it is a significant portion on privacy and those two subcommittees, but it doesn't really address that population --
DR. COHN: I stand corrected, because it does the standards and security, it does privacy and confidentiality, it does the national health information infrastructure. I think it in some ways addresses quality tangentially. It doesn't specifically address the population subcommittee. I do stand corrected.
DR. GREENBERG: Which is why we have the '96-98 report that at least those of you who were at the executive subcommittee saw is off the press, and it will be sent to everybody. But in those areas, it pretty much refers to this report.
DR. SCANLON: So we could ask the committee and subcommittee members to look at the outline and the draft to see whether there are changes they would make to the outline, at any rate, and any new issues they would want to -- I can begin on the factual progress, the date stuff. We can probably condense that somewhat.
But the two areas that are really interpretive are what the committee wants to identify as any special concerns, special areas of emphasis or special -- and these are the last two sections of any report, implementation issues or areas that the committee may want to direct attention to.
DR. ZUBELDIA: One concern that I still have is that the message has not got to the providers yet.
DR. SCANLON: Yes, communications.
DR. ZUBELDIA: I think the payors now know that this is coming. They are not ready for it, but they know it is coming. But I think the providers have not got the message yet. They don't even know it is coming.
DR. FYFFE: Denial.
DR. BRATHWAITE: Kathleen said denial. Those that do know about it expect their vendors to handle it for them. It is the vendors that we have not been reaching well enough, I suspect, with the ideas that the vendors should be putting together their communications to their clients and informing them about what is going on, and sending them a bill.
DR. SCANLON: So it is both a communications and a readiness issue particularly, isn't it?
DR. ZUBELDIA: And there is a problem with implementation. I don't ow if there is anything we can do about it or not. You probably have heard about the shortage of IT programmers. That has created a problem for Y2K. that is noting compared to the shortage of EDI programmers. There are very, very few programmers that understand EDI transactions.
In fact, I was making a presentation a couple of weeks ago to a payor in their shop with the whole management staff, and the person asking me to make the presentation was saying, don't tell them too much about the shortage of programmers, because I don't want to lose my programmers, not knowing about the shortage, and go elsewhere. It is going to be a real problem. I don't know what we can do about that.
(Simultaneous discussion.)
DR. GREENBERG: I was just thinking through the process from last year, and I think there were some questions that delayed the report concerning committee members submitting additional views, which I think is now a policy that committee members can submit additional views, and they will be included.
I know this is a tight time frame anyway, but I think when we send it out, we want to send it out a few weeks before the February meeting, and alert people to that. If they have additional views, they should at least bring them to the meeting. But I don't think we would vote on their views; they would just be included, but I think it would be good to give people a heads up on that, so that it doesn't get delayed and bogged down again.
DR. COHN: And of course, the issue of what additional views you put in depends on how the committee decides to pass in the main body what gets changed and what doesn't. So it may be a little premature to ask people in February to write additional views as opposed to think about what they want to have changed.
DR. GREENBERG: Exactly, since there won't be another meeting until June, we should have a process. So since you don't have to vote on additional views, there will be something like two weeks to give people an opportunity after the finalization of the report, but just thinking ahead.
DR. COHN: And describing additional views, we were talking about trying to put together a conference call to make sure we had the views of this subcommittee to make sure that this represented us, and when we got together in February that we had been through a version or two of this.
Jim, I have to look to you for some guidance in terms of your timing. You have already asked for people to review the current document and provide input. I know Kepa and others have provided you some verbal comments, but there is likely to be some email with additional thoughts.
Now, when do you think it would be useful in terms of having a first draft version that then we can do a conference call on?
DR. SCANLON: When is the conference call?
DR. COHN: When would you like to have the conference call?
DR. SCANLON: I think my biggest concern is making sure we reflect the committee's views. We can readily do the updates and the progress and that part of this.
If members of the subcommittee can get me their ideas for those latter sections of the report and other ideas about what we could streamline or other issues within two weeks, I can begin pulling that together. To some extent, this is a moving target, because the proposed rules and the final rules themselves may be moving along as we are drafting or considering this at the February meeting. So we will always have to reserve the idea of catching up, but the full committee meets the lat week in February.
DR. COHN: And we need to have a meeting probably before our February 1 meeting. Where we have two conference calls on January 10 and 13, do we want to add another one that week? Would that be too early?
DR. SCANLON: I would hope to have at least a rough draft by then.
MR. BLAIR: A personal request only for Jeff Blair is, if it is possible that you could include a weekend from the time you send it to us, because that is when I have my readers available to read?
DR. SCANLON: Sure.
MR. BLAIR: Thank you.
DR. FYFFE: So we have two conference calls already scheduled the week of January 10. Are we proposing a third that week, or can we wait to the week of the 17th?
DR. GREENBERG: The following week.
DR. FYFFE: And Monday, the 17th of January, is a holiday for Martin Luther King.
(Discussion off the record regarding meeting dates.)
DR. COHN: This is a long enough report that it is hard to have a two-hour conference call and digest and deal with the whole thing anyway. But at least it provides some early input, because the hope would be that we would have another version generated for the February 1 discussion and this give us enough time to do that.
DR. SCANLON: And the focus would not e on a line edit, but rather a content edit in terms of what should be there and what shouldn't be.
DR. COHN: Are we okay with that?
DR. GREENBERG: It's up to Jim.
DR. SCANLON: Yes, I'm okay. But please have folks from the subcommittee and staff look over the outline for last year and the report itself, and email me any proposed changes, any areas that we have discussed, or any others that are big concerns.
MR. BLAIR: Many times the documents are mailed to us. Can I assume that this would be in the form of an email distributed to us?
DR. SCANLON: It is already on the website. You mean the draft?
MR. BLAIR: I mean the draft.
DR. SCANLON: Sure.
MR. BLAIR: So since it is by that Friday, you were already anticipating that it would be that Friday before the weekend?
DR. SCANLON: Yes.
DR. GREENBERG: The area of privacy and confidentiality, I would think this report can just rely on the comments that the full committee is going to be making on the MPRM. I don't know if the period is extended whether we want to make additional comments, but it is not my impression that that would necessarily be the case. So either way, that would be an area that had been vetted already.
DR. COHN: I knew this would work, but you all know I'm an optimist. I knew we would get through the clinical data standards piece yesterday.
Now, the other issue that I wanted us to vet for a minute and get some input has to do with priorities on topics for hearings next year. Let me just run through the current thoughts as well as some of the timing issues.
Now, there are a couple of issues that we need to be addressing. First of all, from a statutory responsibility, we do have responsibility to be tracking implementation identifying new standards needed, changes, this whole standards implementation issue.
Now, my belief is -- and this is based on some discussions we had -- is that probably that sort of hearing, which is going to be very important, will probably not be very useful until several months after implementation. This is not going to be something where two weeks after implementation we want to start holding hearings on how is implementation going, and what sort of changes would you like to have.
DR. FYFFE: Can we clarify our terms? When you say implementation, what do you mean? Are you talking about the two-year period after final rules are published, or are you talking about a few months after final rules are published?
DR. COHN: I'm talking about a couple of months after. Once the rules are final begins the implementation phase; implementation is required after two years.
DR. FYFFE: But they are not required to be fully implemented until two years later.
DR. COHN: Correct, but implementation begins, and it is our responsibility to track implementation, make recommendations to the Secretary about changes, new standards, et cetera, et cetera.
MR. BLAIR: My thoughts on this -- and this isn't 100 percent true, this is a generality. Probably the folks that are going to be most aggressive in going through the rules to see how it is implemented will probably be the vendors, because they need to get that into their system as quickly as possible. They are going to have business opportunities by having these functions and features and characteristics there. So they are going to be early on. The users -- of course there are always exceptions, when you have certain large users that may be doing this on their own, but for the most part, the users will wind up implementing the systems that the vendors have.
So my thought was that we might begin to get some fruitful critiques and comments from the vendors early on, in terms of either the difficulties that they may be having implementing the system, or any other issues that they may be having as they go forward. So my suggestion is, we focus first on hearing from vendors with respect to their implementation experiences.
DR. COHN: And other early implementers.
MR. BLAIR: Yes, and other early implementers.
DR. BRATHWAITE: I just wanted to remind people that we are not just doing this because we need to write a report about how implementation is going. The administrative simplification law includes the power of the Secretary to re-issue a final rule before the one-year deadline is up, if there is a need for implementation purposes, so if people are running into difficulties implementing because of something we have done in the final rule, we can issue an update to the final rule very quickly and get that fixed according to the law.
So you are the eyes and ears of the department in that implementation period, as to whether or not the Secretary should invoke that emergency clause.
DR. COHN: I hear through those comments that you are speaking for a relatively early hearing to identify if there are some issues after the initial dates of implementation?
DR. BRATHWAITE: Right. I think the early implementers should already be working on it, since as someone pointed out, Kepa, I think, the actual EDI standards, the implementation guides, have been final since June.
DR. COHN: Other comments? When I talked to staff support earlier, we were thinking potentially of waiting six months from the actual date of implementation for our first hearing. I am being persuaded on the basis of this discussion that maybe a first hearing around early implementers and early issues and concerns may be appropriate, in other words, some time probably late spring.
Let's get back to the logistics of the issue. Probably there will be a session that is some combination of the subcommittee and the work group between the end of March and the beginning of April, and then something in mid to late May, and then probably something in September. From there, I can't see that far because there are fiscal year issues.
I am being persuaded that -- my original thought that September should be implementation focused, but I am being persuaded that probably late May we ought to be getting into these issues. What are the thoughts of the subcommittee?
DR. BRATHWAITE: Maybe in the summer. It depends on the timing of other things, but September could be perfect. But if we hear that things are not going well for some reason, people are complaining a lot about not being able to implement, we might want to move that kind of hearing up to summer or even to May.
DR. ZUBELDIA: We also need a draw a baseline of where we are today, so we can measure the impact of implementation. We talked about that in the previous meetings.
DR. COHN: I think comments about that are going to be included in the implementation report, right, Karen?
MS. TRUDEL: Which report?
DR. COHN: Where we are now.
MS. TRUDEL: Yes.
DR. COHN: I don't know that that is necessarily a hearing issue, except unless it has issues on implementation.
DR. GREENBERG: Where are those discussions right now with Faulkner and Gray? What is the status of them?
DR. SCANLON: I remember where it left off. One of the ideas was for looking at a baseline and then monitoring implementation of the standards through industry resources, and one of those industry resources was the Faulkner and Gray survey and annual data directory. I think at Simon's request, we had staff contact them to look at their overall survey form and talk a little bit about how their survey is conducted. They are actually quite interested, and they send material to some of our staff, Judy Ball.
The biggest concern obviously is that they don't survey every provider or every hospital or every plan. It is somewhat of a selective sample, and it is usually responders to the previous year's survey. So there is this issue of what is a representative, exactly.
But on the other hand, I don't think anyone has a survey like that, nor can anyone do such a survey. It does provide some indicators of the extent to which some of these things are -- there was some interest on the part of Faulkner and Gray related to the actual HIPAA standards. But at any rate, it could be a baseline in terms of one of the better industry sources.
I think that was mentioned in last year's implementation report, that the committee would look at as things moved along some ability to monitor quantitatively the implementation, looking at industry sources. So this is quite consistent.
What we can do is have staff follow up a little bit further to see where things were left off, and then talk to the committee. The only other possible worry would be that the publisher would view some of this as proprietary information, and then I don't know -- it can't be shared, in which case we will have to see how much we could use it.
DR. COHN: So do a followup and then we'll talk about that during the conference call, probably.
DR. GREENBERG: If you want to add questions, the sooner we let them know, the better. When do they survey?
DR. ZUBELDIA: This year it will be in February. The month changes every year. I think it is like every 11 months or every 13 months, but I know it is not always the same month.
DR. SCANLON: To some extent it goes over several months. I think the '99 directory is published, and -- no, they are probably working on the '99.
DR. COHN: I think we captured that, and hopefully that is a to-do item. I think what I have heard from everybody is, traditionally NCVHS does not have a lot of hearings in the summertime. The Subcommittee on Populations is also holding a hearing in the middle of the summer, but it sounds like there is interest and willingness to schedule a hearing someplace or other, we'll decide on the site. New Jersey.
DR. GREENBERG: If you do want to have one anywhere other than Washington, the sooner we know, the better.
DR. COHN: So what we would do is to schedule a summer hearing focused on that, and we would check with people in terms of dates and availability for such a hearing.
The other issues that I have on the plate here have to do with conformance and performance testing, which to me is -- they are not the same issue, but they are very close. Since you can't tell whether you're in compliance or not, there is an enforcement issue unless you do conformance testing. That is the relationship there. But enforcement is an issue that needs to be -- we need to have hearings on at some point this year.
There is also the issue of code sets, and not so much code sets per se, but the issues of moving to new code sets, what are the issues, concerns; are there also other concerns from industry and others in relationship to code sets, the whole issue of code sets.
Those were the issues that I have on my plate from previous discussions as well as from our work plan.
MR. BLAIR: Could you just clarify for us, when you say code sets, we have had our discussion on medical terminologies as an umbrella, and Marjorie pointed out classification systems may or may not be part of that. When you say code sets, could you give us some examples of what does that include?
DR. COHN: I think a code set includes any classification, nomenclature or terminology, and that is what we mean in this discussion. The focus is not -- the focus that we were taking had to do with issues of migrating from one version to another, and issues for the industry and others, but more along that generic level of discussion.
There are probably some other issues related to that, which don't immediately come to mind.
DR. ZUBELDIA: There is a code set that has been brought to my attention for alternative medicine, anywhere from acupuncture to pressure therapy and all those alternative medicine practices. They have developed a code set; they wanted to become a standard, and they want to know what to do about it.
DR. COHN: They testified for the Work Group on Computer-Based Patient Records around the adequacy of their code set as a medical terminology for PMRI. My bet is that they are interested in it as being a procedure system to be used in the claims processing process. So I think that is a very different use.
DR. ZUBELDIA: There are some technical issues behind it, because the qualifier on code sets is not part of 4010. So the only way for them to use a code set would be to either migrate to a different version other than 4010, like 4030, or to have the Secretary adopt that qualifier under 4010 as a retrofit of some sort.
MR. BLAIR: They were also making contact with the Data Council that focused on terminologies, and with the National Library of Medicine to be -- and I think they agreed to be part of the new MLS. Are you saying that for some reason when they were working with the Data Council, they were not included in the HIPAA regs? I remember that was an issue that was coming up as to whether or not they would be. I'm just trying to understand why it is coming up again.
DR. SCANLON: There are a lot of other classification systems that are not part of the administrative simplification standards, that are not referenced in our HIPAA, and therefore are not referenced as standards in our transaction code set regulation. There are a number of other code sets. You heard from the nurses who had two or three, in fact, and you heard from other groups that have their own set of classification proposals and things they were working on.
The original cut was that code sets would be included to the extent that they were included in these transaction standards. Therefore, they would have to be included in the transaction regulation by reference. But these others that are not yet following in that purview. I don't think there has been any official action one way or another to designate them.
DR. COHN: My understanding of the role of NCVHS is to hold hearings on these sorts of issues as they come up, and to advise the Secretary on expansions and changes to the standards. That is the type of thing that we need at some point to put into the schedule and plan, though I don't think I would hold hearings on that particular issue, but the more general issue. But it does begin to beg the question of when -- from my own view, waiting for HIPAA implementation to occur to begin with. Then we have to ask at that point about how implementation is going, and then after that begin to say what sorts of changes, additions, expansions, modifications need to occur.
Anyway, that was how I conceptualized it. We can reorder this however we want. Kepa, what are your thoughts on that?
DR. ZUBELDIA: There has to be at some point a migration to version two of the transactions, whatever version two happens to be. And code sets is part of it. There are also additional implementation guides for the existing transactions. I know that referrals have been looking at three or four additional implementation guides. So we need to see the migration of these transactions.
DR. COHN: That is the sort of thing we had talked about including in our September hearings on an annual basis, to explore what is up, what is being changed, what should be changed to the implementation guides to be adopted in the next round.
We are making this process up as we go, because this is the first time we are having to do all of this stuff. Is September a reasonable time for that topic, based on what our view of implementation is going to be at this point? Or is that too early for a discussion around changes and expansions and otherwise?
DR. SCANLON: If implementation is going well and there aren't major problems in implementation, then I would think it is a very good time. If implementation is going poorly and there are problems, we need to have them flushed out, that is a good time to do that.
DR. FYFFE: It's a good target date. As time moves on, we'll get more information. But I think that is a good initial target.
DR. COHN: So what I am hearing is mid-summer for early implementers and then probably sometime in September as a hearing date for changes, modifications, expansions, whatever to the various HIPAA regulations, and probably supporting code sets and all of that.
We have handled a couple of these issues. I'm getting a little concerned as we've talked about code sets as separate from all of that, in the sense that that is such an open issue. If we were to do something with that outside of this issue of recommending to the Secretary additional HIPAA standards, we need to be very careful about how to structure that.
I think the question would be, in the spring is there any interest in the enforcement/conformance issue. Is that a reasonable time for that sort of discussion? I know things are beginning now; would that be a reasonable time for there to be some discussion about that? Too early? Okay.
DR. ZUBELDIA: A slightly different topic. Are we going to revisit the first report of injury? There is now an implementation guide for 4010 for the first report of injury.
DR. COHN: I would expect that to be an issue that would come up in the September meeting. I think that is a perfect sort of discussion to be brought up with that, I would imagine, unless there is someone who feels that it is compelling that we need to do that before.
DR. ZUBELDIA: There is also a lot of activity on prescriptions, especially with Internet pharmacies. They want to be able to take prescriptions over the Internet. NCPP has a prescription transaction. There is an item going on that will start in the next three months, and have a demonstration and all that.
DR. COHN: So I guess we are getting pretty clear on what we're going to be doing in the middle of the summer and in September. I think the only question is, do we want to do anything, because we know we will still have the CPR recommendations on our plate, hopefully to go to the NCVHS for final approval in June. So the question is, do we want to consider any hearings or any issues that we want to explore, make recommendations on in the spring time frame?
DR. GREENBERG: I know we had had some discussion about some generic issues around migration to newer code sets or updated versions and what that process should be, what types of tools need to be available. I can't remember all the particular issues we discussed.
There is the issue of migration to specific new versions in diagnosis and procedures in particular. But then there are some generic issues related to ownership, things that we were talking about yesterday with the terminologies as well. But distribution, dissemination, what types of tools, if you're going to put in a new code set, what types of things do you need, when do you need them.
DR. COHN: What is the interest of the subcommittee in terms of a hearing around those issues?
MR. BLAIR: Let me see if I understand a little bit. Marjorie, are you beginning to take us down the path where we are looking more and more at not only automated tools for encoding clinical information into an information system, but the use of terminology that is embedded in the information infrastructure as a data dictionary, so to speak, and what the issues are related to the tools or maintenance or updates of that?
DR. GREENBERG: I don't think so.
MR. BLAIR: No, the second issue is not part of it, but is the first one part of what you're saying?
DR. COHN: If the industry is going to move from the current version of ICD to another version of ICD, what is it going to take, what sort of tools are necessary, what are the industry concerns, how do we support the country -- how the country needs to be supported in that sort of a migration if that sort of thing is going to happen. I think that is a little different than what you had described.
MR. BLAIR: Yes, okay, thank you.
DR. GREENBERG: Then there is the whole issue of frameworks for procedures that are still being carried on the work plan in some way. That is still part of this subcommittee.
DR. COHN: And this cuts across the subcommittee work group. This is just another cut on issues that we've talked about for the last day and a half.
I think we need to do a little more work trying to further clarify and define this one. What I will do is to work with Marjorie and I think also with Jeff to see if we can come up with the issues that we may want to discuss for this one. Unfortunately, the enforcement and conformance issues -- the general feeling is that enforcement will not be -- it will not be timely to have a hearing this spring on those issues, and I am hearing some agreement on that. So we can grab that later on.
So we can decide at our January-February meeting whether we want to have a set of hearings on these particular issues and/or email back and forth, conference call, whatever, as seems appropriate. What we will do is, we will do some coding for people for one or two dates in the spring, but early and late spring so that we have time held. We already know we're going to need some time for the CPR work group; do we also hold another date as a possible hearing date. Is that okay with everyone?
DR. GREENBERG: Late March, maybe?
DR. COHN: Late March, early April and then some time in late May.
(Discussion off the record regarding meeting dates.)
MR. BLAIR: When you take a look at the tasks that Simon has reviewed, what our responsibilities would be, I think that those responsibilities appear to be driving this type of a calendar.
DR. COHN: I think we know that we are going to have one meeting in the spring. We just want to have people hold, and then we can make an intelligent decision later on about whether we go on with the second one or not, based on whether we are convinced that the hearings would be useful and that the issues are pertinent at the time.
It is now 12:15. I would ask anyone if there are any other issues that we have for the moment that need to be brought up before we adjourn.
DR. ZUBELDIA: I would like to offer to the department to let us know if there is any special pressing item which we could help with, maybe issues with patient ID or the provider ID system,distribution of the provider IDs or assignments, anything that we could help with, let us know.
DR. COHN: We should expect for the January 31 meeting -- we will be focused on CPR work group issues and the next version of the clinical data standards. We should all expect that we'll spend some time on the first as we have to date dealing with subcommittee issues and based on the agenda and the issues, we will meld the two activities together.
DR. GREENBERG: And the HIPAA reports.
DR. COHN: Yes, the HIPAA reports and maybe some other issues that come up. If claims attachments are out, we may need to come up with -- discuss the response to the claims attachments MPRM.
I want to thank you all very much, and the meeting is adjourned.
(Whereupon, the meeting was adjourned at 12:18 p.m.)