[This Transcript is Unedited]
Hubert Humphrey Building
200 Independence Avenue
Washington, D.C.
DR. COHN: I want to call this meeting to order. This is the second of two days of meetings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee is the main public advisory committee to HHS on national health information policy.
I am Simon Cohn, chairman of the subcommittee and the national health information policy director for Kaiser Permanente and a physician.
I obviously want to welcome fellow subcommittee members, HHS staff and others here in person. I also want to welcome those who are on the internet.
I want to remind everyone here to speak clearly into the microphone, so those on the internet can hear us.
The focus of these hearings has been on HIPAA administrative simplification and understanding the DSMO process, as well as recommendations and general industry issues around readiness.
Now, we have heard a lot of testimony yesterday. The purpose of today's session is to discuss what we heard yesterday and identify any recommendations we need to make to NCVHS that then can be forwarded on to the Secretary as advisory.
With that, I think we will do introductions around the table. If you would also, while you are introducing yourself, those of you on the subcommittee, if there are any issues to come before the committee today that you believe you need to recuse yourself around, would you please so indicate.
I guess I should start, although I am not going to recuse myself around this one. I am a member of the National Uniform Claims Committee, which is one of the DSMOs.
DR. BRAITHWAITE: I am Bill Braithwaite, HHS staff to the committee.
MS. FYFFE: Kathleen Fyffe. I work for the Health Insurance Association of America. In that capacity, I represent HIAA on the National Uniform Claims Committee, the National Uniform Billing Committee, the National Council for Prescription Drug Programs, and HIAA is also a member of the work group for electronic data interchange. I am a member of NCVHS.
DR. ZUBELDIA: Kepa Zubeldia. I work for Claredi Corporation and I am the new chair of AFEHCT, Association for Electronic Health Care Transactions, a member of NCPDP, X12, ASTM and WEDI.
MS. GREENBERG: I am Marjorie Greenberg of the National Center for Health Statistics, CDC, and executive secretary to the committee, and a member of the NUBC.
MS. BEEBEE: I am Susan Beebee for NCHS. I am a member of X12, HL7 and WEDI.
MR. BLAIR: I am Jeff Blair. I am vice president of the Medical Records Institute. I am vice chair of the Subcommittee on Standards and Security, NCVHS, member of HL7, member of ASTM, member of ANSE HISP.
MR NAMINSCHON: Stanley Naminschon from the Health Care Financing Administration, serving as staff to the committee today.
MS. ADLER: Jackie Adler, National Center for Health Statistics.
MS. WARD: I am Maria Ward with First Consulting Group. I am vice chair of the DSMO steering committee.
MS. WEIKER: Margaret Weiker, EDS, DSMO chair.
MR. MONGER: Don S. Monger(?), government relations manager for the American Health Information Management Association.
MR. LANDEN: Richard Landen, Blue Cross Blue Shield Association.
MS. WILLIAMS: Michelle Williamson, National Center for Health Statistics.
MS. IORWAKOWSKI: Bernie Iorwakowski(?), American Optometric Association.
MR. CUTRILL: Rusty Cutrill(?), Metal Computer Systems.
MS. ALT: Vivian Alt, National Library of Medicine.
DR. COHN: Let me review the agenda for the moment, just so we know what we need to get through. This is how I think we need to parse things apart and if you have any additional suggestions, let me know.
The first item is to really reflect on what we know from the DSMO presentations about what we need to recommend in relationship to the DSMO recommendations to NCVHS, as well if there are any additional recommendations we have to the DSMOs about how they need to proceed.
After that, I think we need to take up, probably as a second set of issues, and certainly a second letter, any recommendations we have based on our testimony in the afternoon in relationship to general readiness and implementation issues. Certainly we have heard a lot of them yesterday.
After that, I sent around to most of you a copy of issues for the subcommittee for the year 2001-2002, and I want to just have us all take a look at the issues list, and then reflect a little bit about what we need to be doing for the remainder of the year in relationship to hearings or other activities. I think that will be hopefully a useful discussion.
After that, we need to talk a little bit about the June breakout that we have, which I think is supposedly scheduled for three hours later on this month, about how we want to fill that time.
Finally, there is a letter from external code set users that I wanted to reflect on, about how we needed to respond to them. Is there anything else we need to handle?
MS. GREENBERG: There is a letter that John forwarded to us.
DR. COHN: There have been two or three letters that we have received in relation to a particular external code set. I think once we have an idea of what our plans are for the year, a response to these letters will hopefully become sort of obvious. That is the hope anyway.
DR. COHN: So, we reflect a little bit about the DSMO process. I want to start out with a couple of observations, and I would certainly invite our DSMO co-chairs to feel free to comment as I wade into some of my introductory comments here.
First of all, I have reviewed, relatively extensively, the recommendations, especially the As and the Cs. I certainly would suggest that we support all of the A recommendations, sort of without questions, assuming whatever results of appeals processes there are, but generally As seemed to me to be relatively non-controversial. Certainly the Hs are things that we would wait for further direction from the DSMOs.
As I was reflecting a little bit on the time line, assuming there aren't any other delays in the implementation, I think that even though we heard a lot of concern yesterday expressed by the fast track process, the reality is that without it, there would have been no changes from the initial regs until implementation because of how the time frame went for the change.
Any change, by the time they had made it through the regular DSMO process, would have been much too late for anybody to have even considered putting them in prior to an implementation date of October 2002.
Now, having said that, I think the DSMOs need to understand, especially as we look at the Bs -- which I am not going to look at these, but they need to reflect on the Bs -- are there any there that ought to be implemented prior to October of the year 2002.
That would, I think, really be the question I would have for them, in terms of whether some of the Bs should become As or not.
I am fine with them not, but I did notice that a number of them were either relatively minor changes or things that actually took some things off or, in some other cases, clarification.
With the recognition that whatever happens as a result of this is likely to be static for the next year and a half, I think they are some important issues for the DSMOs to mull about.
I guess I should ask around the subcommittee as I say this. These are personal opinions of one subcommittee member. Do others generally agree with the things I have just been saying? Kathleen is nodding her head yes.
DR. ZUBELDIA: I think the distinction between A and B and sometimes, as we have seen by the appeals, sometimes it is not very clear.
I would have a tendency to push them more toward the A side and just get it done. If you know it is an issue and it needs to be corrected, there are some people that believe it is critical, if at least somebody in the DSMOs believe it is a critical issues necessary for implementation, I would have a tendency to get it fixed, if it can be fixed within the time frame.
That is a decision the DSMOs need to make, but I would like to see more things fixed up front that you know are broken, rather than postponed.
DR. COHN: Jeff, do you have a comment on this?
MR. BLAIR: No, I support this discussion.
DR. COHN: Stan, I guess I should ask, since you have been very involved in this process, do you have any comments you would like to make?
MR. NAMINSCHON: Just in terms of the process, I think it is important to realize that making the changes has to go not only through the DSMO discussion, but also back to the standards developing organizations for X12 and/or NCPDP to do their work.
In a number of cases, I think especially on the Bs, there was a realization that the change could not be made in such a short time frame.
That is why there was certainly a recommendation that a change needed to be made, but it needed to wait until the next version, 4040, 4050 or whatever it is, of the X12 standards, for that change to become effective.
DR. ZUBELDIA: I have a question on process, and correct me if I am wrong. As I understand the process, the DSMOs are going to come to the NCVHS with recommendations for changes, and then we will have to move those to the Secretary with recommendations for changes.
If the DSMOs don't agree on something, they may or may not recommend it to us. We may or may not recommend it to the Secretary. Is that the correct process?
In that case, I think there is that filtering that needs to take place to prevent conflict later during the NPRM phase.
I think that is a role that we can also play and get the consensus, making sure that the consensus has happened before we recommend the Secretary makes a change. That is, I think, a role that we need to look at.
DR. COHN: I am hearing you. I am not sure I am completely understanding you, only in the sense that I was reflecting yesterday on at least one testifier who observed that consensus is not unanimity or universal agreement.
I would absolutely agree that I think the whole point of the DSMO process is to try to develop consensus, and we certainly want to further that.
Can you guarantee that an NPRM will come out where no one will comment negatively on any of the items? I don't think that is a realistic expectation.
MR. BLAIR: Simon, I am not sure the word consensus is appropriate. I think that the majority decision of the DSMO members is what is necessary. Consensus, in my mind, means that all members of the DSMOs agree. I think in many cases that is not a realistic goal.
I think it would be that it is the decision of the DSMO entity, which means the majority as opposed to a consensus. Margaret, is that correct, and Marie?
DR. COHN: It is actually two thirds, I think.
MR. BLAIR: Maybe it is two thirds. Is that correct?
MS. WEIKER: That is for appeals. Then when we went and voted, there were change requests where a consensus was reached. There was give and take, and there was consensus.
In others, it came down to a vote. So, it is not one or the other. It is typically both. Those that were voted on were typically the ones that are in the Hs, right now.
MR .BLAIR: In terms of NCVHS committee support, what should be the threshold that you think we should consider?
DR. COHN: Jeff, for our vote or their vote?
MR. BLAIR: For our support.
DR. COHN: We vote and we decide on the basis of a majority on what should be moved up to the full committee.
MR. BLAIR: What I meant was, should we wind up saying that we support everything as long as the DSMOs approved it, or is it that it has to be at a consensus level, I guess is my question.
DR. ZUBELDIA: I think that the question centers on the appealed issues. We move those forward knowing that they have been appealed, knowing that there is disagreement among the DSMOs, or should we hold those back until they reach agreement, maybe through a later phase?
DR. COHN: They have no recommendations on the -- Margaret, maybe you can help me on this one, because one of my questions was going to be the next steps of the DSMO process.
My understanding is that there is actually nothing today that we could move forward, because everything is subject to appeal; isn't that correct?
MS. WEIKER: Yes, that is correct at this point. As of yesterday, the appeal process started. A requester or a collaborating DSMO has seven calendar days to file an appeal.
Once that seven calendar days is over with, then they have an additional seven calendar days to provide additional documentation to substantiate the appeal.
At that point, then the DSMOs, all of them, will meet and consider -- whether collaborating or not -- will meet and look over the additional documentation.
Those of us that didn't opt in will go back and look over the original change and the recommendations, et cetera.
During the appeals process, every DSMO has a vote. In order for it to move forward, so to speak, there has to be two thirds of all the DSMOs that would approve a recommendation.
That is why I say it is approximately a 20-day window in there. We have got the seven calendar days, so that is 14. Then we have to distribute that information to the DSMOs and schedule a meeting, so that we can then discuss that. We have to give at least a couple of days so that everybody can look at the documentation.
MS. GREENBERG: A two-thirds vote to overturn your original decision?
MS. WEIKER: Yes, to overturn the original decision or say, this is what we are going to do; now that we have seen this, this is what we are going to do. It takes two thirds of the voting. HCFA is a non-voting member of the DSMO, but they do participate.
DR. ZUBELDIA: Margaret, what happens if the original submitter is not happy with the decision of the appeal? Can that same issue be brought back through the non-fast track process, through the normal process? Can it be brought back again?
MS. WEIKER: Yes. If it was categorized as a no change and then they appealed and we say it is still a no change, and if they think it really is a change, they can bring it back.
DR. COHN: Kepa, at that point, it would probably show up in a future implementation.
DR. ZUBELDIA: That is what I am saying. Anything that doesn't go through this time around through the fast track can still be done through the regular DSMO process next year.
MS. WEIKER: Right, the category Bs will go forward. It is just not in this addenda. There are some of those category Bs that are going to require data maintenance to X12 in order to implement that.
We realize it needs to be done, but it requires data maintenance or a higher version of the X12 standard, so we can't do it right now, unless we move everything to version 4050 or whatever.
DR. COHN: Margaret, just to help me on this one, are you -- it sounds to me from your time line that you will have results and recommendations by late in June. Is that correct?
MS. WEIKER: I would hope so.
DR. COHN: Okay, as well as areas where you all just could not reach agreement, I suspect. We will find some of those.
MS. WEIKER: Yes, I hope to have it done by the end of June, first part of July.
DR. COHN: I guess I am just sort of looking. Based on our discussions -- and maybe I am jumping a little bit -- but the full committee meets on the 27th and 28th, and the subcommittee meets on the 27th.
It might be useful, if there were recommendations at that point, that would be a good time to bring them forward.
I mean, we have seen the preliminary recommendations. I think most of us are comfortable with -- once again, hypothetically speaking -- with the As and the Cs that you have brought forward, recognizing that there is a known controversy that will continue, and certainly there are a number of issues, as I think Kepa is observing, where there are already Hs and there are likely to be probably some more.
MS. WEIKER: I know there will be.
DR. COHN: So, the question would be, if we can get the final set of recommendations by that time, then we can move them through the NCVHS process. Otherwise, we are going to have to do a phone vote for NCVHS or wait until September, which is probably a little late from what we all want to do.
MS. WEIKER: That is too late.
DR. COHN: I guess this may solve my question about what we are doing in June, but certainly it may make sense for us to take a look at, not so much at the As, but the ones that have been appealed, and look at those sort of closely to make sure that everybody is sort of in agreement, and that there aren't some major industry issues that were not immediately apparent to people.
As I said, I am very impressed with the overall DSMO process, even the fast track expedited process. I think a lot of thought is going into it and you are doing a very good job getting relatively wide comment.
Obviously, our responsibility here is to make sure that there aren't any unforeseen industry consequences from groups that are really not part of the DSMO process.
I don't think that we need to re-discuss the internal strife of the DSMO process, say, but it would be useful also to hear how things get resolved in terms of appeals.
Kepa, is that sort of where you are going also? I mean, I presume you agree that we need by June to kind of wrap this set of changes up.
DR. ZUBELDIA: That would be ideal.
DR. COHN: Certainly, from my view, I would say if you can look at the Bs, if there are any that slip into As, I think we would be fine with that, but I am sensitive to the time frame and that may preclude any of that happening.
As I said, it seems to me that we need to, I guess from the subcommittee's view, somehow begin to draft a letter that whatever it is that we decide in June to go to the full committee, could be attached, and I think we talked about this yesterday, a letter from you along with the recommendations for changes, that then the NCVHS could put a letter to the Secretary and move it forward.
DR. BRAITHWAITE: If we could have all that ready for that day.
DR. COHN: Exactly, that is what I am thinking.
DR. ZUBELDIA: Would it be useful to indicate in the spread sheet which issues were voted on because there was no consensus?
MS. WEIKER: Useful to who? That spread sheet was never intended to be widely distributed. That spread sheet was to be used as an internal working document for the DSMOs.
If you go out to the DSMO web site, you will not see that spread sheet. You will not see X12N's comments or the NUCC's. You will see the final DSMO comment. We want to present a united front, and that is the way it should be, versus showing everybody's comments and getting confusion where confusion sometimes already reigns supreme.
DR. ZUBELDIA: It may be useful for the department to assess the comments during the NPRM process.
DR. COHN: Kepa, I guess the question is, do you want the department to have them selected out or do you want the subcommittee to have a chance to review those pieces that were appealed?
DR. ZUBELDIA: We are talking about two different things. I am talking about the NPRM review. During the NPRM review, there may be a vocal minority that dissents on a specific thing, or it could be that the submitter of an issue dissents on it. You would kind of like to know what is happening there. If there was a consensus during the DSMO process, and then the NPRM has lots of negative comments, I think it is useful information to know whether there was consensus or not.
DR. COHN: I am losing a little bit what you mean by consensus. I don't know whether a consensus is two thirds or a consensus is everybody voting. I recognize that it doesn't go forward with the appeal unless there is two thirds. I guess I need a little clarification. Marjorie, do you have a comment on that?
MS. GREENBERG: It is time to provide a caution from the experience of this whole process. That is, I think it certainly would be helpful, probably, to the subcommittee, the full committee and even the department to know whether there are some areas where there is still a lot of contention, as kind of a heads up.
I would assume that actually Bill and Stanley -- well, Stanley, you actually participated in the process, didn't you, as the HCFA representative, and you have a fair sense of that.
I also would caution against really getting too involved in second guessing, et cetera. I have personally and professionally learned through this process that we are committed in the department to working through the voluntary standards organizations.
Even when the department had some people on the data council who felt strongly that maybe something should be different than what was in the standard that was recommended by X12, it was agreed that we had to go through the X12 process, that only in cases where it would be quite extreme would the department second guess what was decided through that process.
I think that probably shouldn't be any different in this case than it was for the overall standard. Otherwise, it just would be a different standard that you would be using for reviewing this, if you really started getting into that.
Frankly, everything in the standard, you know, we don't know what kind of level of consensus there was. Things that are already there that weren't even questioned, they went through the process, we have bought into the process, we have basically kind of blessed the process.
I think that it should have to be a very high standard to start to question it. Yes, you can have hearings, et cetera, as you have had, and I think the Secretary has a responsibility to the country and to the Congress that goes beyond even just agreeing with what this process comes up with.
On the other hand, I think if you look at how we got to where we are, it wasn't doing a lot of second guessing of where that process took us.
MR. BLAIR: May I make some comments along with that? I feel as if, to some degree, we would begin to undermine the credibility of the DSMO process --
MS. GREENBERG: That is basically what I am saying.
MR. BLAIR: -- if we begin to parse out whether or not the vote was a majority, whether it was two thirds or whether it was consensus, which consensus is what most people, I think, interpret as 100 percent.
MS. GREENBERG: No, that is unanimity.
MR. BLAIR: Then maybe I don't understand the definition of consensus. I thought that is what consensus was.
I think that it is the decision of the DSMO that we should trigger on, as opposed to --
DR. ZUBELDIA: Jeff, I agree with that and with what Marjorie said 100 percent. I think we cannot undermine the DSMO process.
The question I had is, with the NPRM, it is the department that has to respond to all the issues that come up during the comment period of the NPRM. It is not the DSMO. It is the department that has to respond.
The more information the department has to respond, the better. That is my only comment, with no intention of undermining the DSMO at all.
DR. COHN: It sounds like one of our HHS representatives is responding to that.
DR. BRAITHWAITE: Yes, two things. First of all, I think that the value of the NCVHS subcommittee, in looking at these things as an independent body, is recognized by HHS and by HIPAA where it says that we are to rely upon the recommendations of NCVHS, and not rely upon just whatever the DSMOs do.
It is sort of a look by this body at what they have done to say, does this make sense or has something crazy happened in the process. That high level look is important to HHS. That is the function of this subcommittee, as far as HHS is concerned, not only just passing the recommendation on but actually taking a look at what they have recommended and does it make sense, is the process working, those kinds of questions.
When it comes to HHS, when we get comments in response to an NPRM, we have the ability, under the APA, to do fact finding.
If something looks funny or we need to have more information, we are more than capable and willing, under the APA, to call up the DSMO that worked on this or the SSR or whatever and say, what does this mean and can you give us more information before we decide how to respond to this comment.
I think that the process at each of its stages has independent value and we shouldn't be sort of passing the votes and the recommendations of each of the individuals involved up the line because that tends to, in my view at least, bias the results.
MR. NAMINSCHON: Could I just add one thing? One of the reasons that we included the NCVHS in the DSMO and MOU process was to provide actually an open public forum for anyone to be able to come in and say, gee, here are the recommendations. I like them; I don't like them.
So, I think it is important to somehow publicize the fact that the NCVHS is going to be considering the DSMO decisions at a particular meeting, so that people can have the opportunity to voice their opinions, whether they participated in the DSMO process or did not.
The NCVHS is a FACA committee, and we were asked by our office of general counsel to make sure that there is an open public process for this. That is a key element.
DR. COHN: Hopefully this meeting is a part of that.
MS. GREENBERG: As executive secretary of the committee, I certainly value that role of the NCVHS. I didn't indicate that I didn't. I just feel that also we want to kind of keep to the same standard of second guessing certain things.
DR. COHN: Stanley, as you make these comments, we obviously intended to discuss the appeals and what I am thinking of kind of the second report, and recommendations and with a view toward what has happened to appeals and all of that in June.
Obviously, I am concerned, when we have three hours for that session, and if you want to do a major publicity campaign to everyone know, we better schedule some more time in August, I think, too.
I think there is a balance, and we also need to see what sort of comments. One would hope that there will be enough time in June, but we need to think about whether or not -- I mean, if we have more comments than we have time to discuss, we need to come up with other time to discuss them.
DR. BRAITHWAITE: Of course, the committee has the opportunity to comment on the NPRM at that stage as well. It is pretty open ended.
DR. COHN: Sure, as the subcommittee appreciates. This is the first time we are going through this. We have to figure out how it is we want to approach it. Margaret, you are looking like you are going to make a comment?
MS. WARD: Probably. I will try to get those to you as close to June 27 as I can. I will not be able to attend that meeting. So, I will e mail them to you, Simon.
DR. COHN: Will we be able to have a representative from the DSMO to discuss the appeals process?
MS. WARD: Maria, I believe, is on vacation. That is the problem.
MS. WEIKER: I am scheduled to be on vacation that day. One of the things that is becoming challenging for me to personally is to be here every so often. It has been three times so far this year already and it is at the expense of HL7.
So, that is tough from a financial perspective and it is tough from my employer's perspective, plus the other five things I volunteer in.
It is all back to that same argument about time and resources and money. If Margaret and I have to keep coming back here every month or two, I don't think that is going to --
DR. COHN: I guess I agree. I guess at the same time -- Marjorie, did you want to comment?
MS. GREENBERG: I just wanted to say that, on an exceptional basis, the committee does have limited resources to travel people whom the subcommittee feels it is essential to hear from in order to conduct their work.
As I said, it is an exceptional basis because, one, we don't have that many resources and, two, you can get into preferential treatment or whatever.
On the other hand, in this case, where there is this relationship and you really require this continuous representation, I would certainly, as executive secretary, entertain a request from the chair.
I think that is the process. The chair of the subcommittee makes a request from the executive secretary and the chair of the full committee covering travel. I would entertain such a request.
DR. COHN: I think you heard a partial answer. I don't think that that quite solves the problem. I was hearing as much a time commitment as a financial commitment, flying you in.
MS. GREENBERG: We can't cover that.
MS. WEIKER: If I choose to spend a vacation day that way, that is my choice and I can do that. Part of it, too, is the cost.
DR. COHN: On a larger issue, I think the question gets to be whether one of the co-chairs needs to be here or whether you feel comfortable delegating it to one of the members of your coordinating council. I think you do have some discretion about how you want to handle that.
I think we are sort of in a situation where -- you obviously have a number of options. You can mil us your recommendations and hope that we will consider them in the light in which you have sent them, recognizing that there will probably have been some vigorous appeals process going on.
You can make sure that you have either yourselves or delegated some others to come and help the subcommittee, and hopefully the full committee if needed.
Actually, I doubt it will be a full committee issue, but primarily a subcommittee issue to sort of understand how the appeals have gone, answer any questions the subcommittee will have around the appeals process.
Obviously, I can't tell you what to do. I can strongly recommend that we have somebody come from the coordinating committee, but I have to leave it to you on that one. Does that help at all?
MS. WEIKER: Sure. I mean, I think we knew that you would strongly recommend that there be somebody here. So, we can talk about that.
Is it your expectation that the events of that day would include individuals coming here to talk to you outside the DSMOs that have concerns, questions, praise, whatever about this process, or is it your expectation that it would be more of a review by the committee of the documentation that they have in front of them and a dialogue about that?
In other words, are you opening it up to the world to come in and tell you what they think, or are you reviewing documentation?
MS. FYFFE: I have a question. Do we have to have somebody here or can we hook them up via conference call?
MS. WEIKER: I was thinking the same thing, Kathleen.
MS. GREENBERG: Certainly, it is possible.
MS. WEIKER: I could spend four hours. I am going to be on vacation and traveling. I could spend the four hours and still get where I need to go without side tracking my way to D.C.
MS. GREENBERG: It is not the whole day. It is just the afternoon.
MS. WEIKER: Do you have a sense of --
MS. GREENBERG: We have had reasonable success with conference calls.
DR. COHN: Let me ask our staff. My sense is that if there is someone from the public sector who needs to come in and feels they need to somehow testify about this, we need to afford them the opportunity.
DR. BRAITHWAITE: Typically, very few people want to do that. They have had their say in the process and, if they have got more to say, they will say it in the NPRM process. Maybe a couple of people will show up, but I don't expect a crowd.
DR. COHN: If we do, we will have to schedule yet another time to listen to all of them that want to come in and comment.
MR. BLAIR: I think we probably want to encourage the people who are concerned about how their views are represented in the DSMO process to work within the DSMO process.
It is only if they feel as if they haven't been able to successfully get those views considered that they would come to us, kind of on an exception basis. I would think.
DR. BRAITHWAITE: I think we should limit public comment at this meeting to the result of the DSMO process, not the process itself. That is another time, another issue.
DR. COHN: Let me think about that one. The problem, of course, is that the next step is obviously the appeals process. By definition, there are going to be some people who are not satisfied with whatever happens. There wouldn't be an appeal if everyone was happy with the initial results.
We just need to mull over the effect of what we are commenting on, in the sense that we would be asking them to comment about the results of what you all come to.
Having said that, of course, we can ask for written comment, which is certainly something we would encourage from those who have issues with the results of the process.
I think we are just going to have to be flexible. I have spent many years doing things for the first time. So, I am not too surprised that we are sort of grappling with what this is going to be like because we have not done this before.
You have not come up with recommendations before, much less an expedited process, nor have you been through the appeals process before.
If we have not taken testimony from you or received recommendations from you, we hope that the process has enough integrity that people will feel they have been heard, be accepting of the results. If not, they will obviously have an opportunity to come here or comment at the NPRM process. I think that is the best we can offer.
MS. WARD: One of our challenges, as will be yours, I think, is to be able to distinguish between the people who are never going to be happy and always complain that they didn't get what they wanted, and the people who may have a legitimate concern or a legitimate issue.
I guarantee you that this first cycle is going to result in people saying none of it works, every one of the DSMOs is broken and the steering committee doesn't work, so now NCVHS, help me, you are my last resort.
That is always a challenge. That is, as somebody put it once, weeding out the whiners. You have to be able to do that tactfully.
MS. GREENBERG: I was just consulting with Jackie Adler about the Federal Register notice for the meeting. Particularly for the full committee, it is pretty general, but if you really want to move forward with recommendations to the department -- it may have already gone, but we can amend it -- it maybe should include the fact that the subcommittee and then the committee will be considering the recommendations coming out of the DSMO process.
That way, there is public notice. Again, you can always limit testimony. You can get written testimony. This is the role, as Bill and Stanley said, of the committee. If you like, we can get that into the Federal Register notice.
MR. BLAIR: Let me see if this view states what our role is or not. My thought is that the NCVHS is oversight on the effectiveness of the DSMO process, and that when an individual group or entity feels uncomfortable with the way the DSMO process has worked, they have the option of coming to us as an example of how the DSMO process might need to be corrected.
So, while we might hear specific complaints, for the most part, we are hearing specific complaints as examples of flaws in the DSMO process, as opposed to us being an appellate entity for a specific decision. Is that correct or not?
DR. COHN: Jeff, I actually disagree with what you are saying. I actually think there is relatively specific legislative language in HIPAA that talks about the fact that the Secretary is to rely on our recommendations.
Our issues are not just, do we like the DSMO process or do we have recommendations for them to improve the process.
Really, our responsibility is to take those recommendations, make sure they are appropriate recommendations and move that forward. So, we are involved with the substance.
Now, we can choose how to deal with that substance, but I think I would argue that actually the next meeting is not about the DSMO process so much. It is more about the recommendations.
MR. BLAIR: If that is the case, then I think as a committee member I will take it far more seriously to review all of those entities, to fulfill my responsibility as a committee member, to really examine each of those things.
Maybe we need to make sure that all the committee members do have the time to really review with integrity each of the recommendations.
DR. ZUBELDIA: Margaret, is there anything that is going to change in section A?
MS. WEIKER: No.
DR. ZUBELDIA: So, all we have to review between now and the end of June is H.
MS. WEIKER: And anything that may appeal that may require us to recategorize something to an A. Somebody could appeal an A -- although I doubt it, you never know -- and it may be that the A becomes a D.
DR. ZUBELDIA: Can you send us the marked up spread sheet, so that we know what the differences are and we don't have to go through the A section again?
MS. WEIKER: The As are out on the addenda web site and it is an attachment to my testimony.
DR. COHN: Actually, let's modify this a little bit because I think Kepa is sort of making it up as he goes here.
I think what Kepa really wants is to understand those items that are being brought up for appeal.
DR. ZUBELDIA: I don't want to have to go through things twice.
MS. WARD: What specific things do you want to be able to focus on?
DR. ZUBELDIA: Anything that has changed from what we have in your testimony today, and if we could get a copy of your testimony electronically so it is better to read, and then anything that has changed past that.
MS. WARD: We won't know that for another 14 days.
DR. ZUBELDIA: When you have it, when you give it to us on the 27th, when it is marked up --
MS. WARD: You want us to highlight the differences between today and post-appeal process.
DR. ZUBELDIA: So we can review it quicker.
MS. GREENBERG: You will know, at the end of seven days, what is being appealed; right?
MS. WEIKER: Right. We just won't know what will happen, the outcome, but we will know what is appealed.
MS. GREENBERG: That really narrows it down.
MS. WEIKER: I could just send an e mail. Who do I e mail? I could send an e mail to say, here are the ones that are on appeal. Send it to Jackie?
MS. GREENBERG: Yes.
DR. COHN: Not to prolong this conversation, but is there anything else that we need to -- I think we are sort of making the process up as we go.
We are saying that we want to see the list of items that are being appealed, and we obviously want to know the results of that, and that will be really the focus, I think, of the discussion on the 27th.
We can certainly invite either one of you to come in, either in person or via conference call, to join us for that discussion.
We are obviously going to publicize the fact that we are going to be make, I wouldn't say final, but hopefully making subcommittee recommendations that would go up to the national committee in June in relationship to these. I can't think of much else to offer at this point. Anybody have anything else we are missing?
MR. NAMINSCHON: At the meeting at the meeting at the end of June you will be considering actually all of the As, all the changes that the DSMOs are recommending, and the final status of the appealed items.
I just want to make sure that I understand. It is not just the appealed items, but it is all the changes that the DSMOs are recommending, so that the subcommittee could pass it to the committee, and then to the Secretary their recommendation on those items.
DR. COHN: I guess maybe I am mistaken, but I thought that the point of the last day and a half was really to listen to the last recommendation, the comments from the industry on the A items and B items and others. I think we heard a fair amount of testimony in relationship to that already.
I think the focus of the testimony or discussion will be on the changes. Certainly, you are right. The intent of the letter and the transmission will be whatever changes need to occur to the financial administrative transactions and the final rules, to make them more implementable.
MS. BEEBEE: Where do the Es fall as far as the subcommittee, with the policy issues?
MR. NAMINSCHON: Thank you. Es are the HHS policy issues.
MS. WEIKER: Yes, there are seven of them.
MR. NAMINSCHON: Those change requests are pended, depending on how the department or how we determine what the final policy issue is; correct?
MS. WEIKER: Let me give an example, Stanley. 134 is the dental claim, the predetermination of benefits to allow the 837 to be used for predetermination of benefits versus the confusion that exists today.
We will recommend that the 837 dental claim be recommended for dental predetermination. Then ultimately that comes down with a policy with HCFA and HHS with whether they adopt that and then take that forward in a final rule or an NPRM, I should say.
MS. WARD: It is not about changing anything to an implementation guide. It is about changing the reference to the use of that implementation guide in a final rule.
Right now, the dental community think they -- and rightfully so -- have to use a 278 to do that, when the 837 dental guide supports that business function, but nothing in the rule allows them to use that guide for that business function.
DR. ZUBELDIA: That is because the final rule says that the 837 guide is used for claims or encounters, and the predetermination is not a claim.
MS. WEIKER: Right, so it is a policy decision, but the request came in through an implementation guide process.
DR. ZUBELDIA: It is a change in the final rule to say that this is used for claims, encounters and predetermination of dental benefits.
MS. WEIKER: Right. I suppose one thing we could do is say, our recommendation is to, yes, make that change, but ultimately you all need to do that if you want to do that. It is not like adding a ref segment or adding a co-value to an IMP guide.
DR. BRAITHWAITE: I agree. It is an NPRM statement for comment, your recommendation to us that it should be allowed is a recommendation to the department.
MS. WEIKER: We will include those, then, in that transmittal.
DR. COHN: Susie, thank you. Any other comments about these Es?
DR. ZUBELDIA: Some of these Es are a little bit intricate. 223, for instance, recommends the use of local HCPCS J codes for professional institutions. It goes back to local codes.
DR. COHN: I read that and I thought they were misreferencing J codes because J codes, by definition, are HCPCS level two codes. Now, are there HCPCS level three J codes, Marjorie, do you know? I don't think I have ever heard of local three HCPCS codes. Level three codes, by definition, are level three codes.
MS. WARD: I think I might be able to end this discussion. The requester thought that they had to use NDC codes. This request was intended to give them more than two years to migrate to NDCs.
Their point was, can we have an additional year to still use local codes before we have to be fully NDC compliant. I think a decision on NDC that we have already heard should make this a moot point.
That is the art of understanding what people mean when they write a question.
DR. COHN: Thank you, since we couldn't tell.
MS. GREENBERG: So, they want to be able to still continue to use J codes.
MS. WARD: The request is that they needed more time for transition from J codes to NDC. With the letter that Karen read yesterday, it is a mute point. That will be a response that we can post back to that request. We didn't know until yesterday.
MS. GREBERMAN: Margaret, while you are still here, there is 228 and 361 dealing with NCPDP. So, the recommendation would be coming.
MS. WEIKER: The recommendation, we have already talked to Stanley and Marilyn Abramowitz with HCFA about these changes, and they are in agreement.
So, as part of the transmittal we send to you will be to -- in the instance of 228, it is to correct an error that exists in the final rule regarding remittance advices.
MS. WARD: Which, by the way, is a pretty big error and people are beginning to believe me any more when I tell them it is not true.
MS. GREENBERG: What about the issue that came up yesterday, the Medicaid pay and chase?
MS. WEIKER: I am on the NIMI list serve, which has all Medicaids and Guam. Anyway, there was discussion at a meeting this week about the pay and chase, because I reported what was the final outcome of that.
Not all Medicaids agree that needs to be part of the initial implementation of HIPAA. So, the person that leads that task group in NIMI is going to send out a survey to see how many Medicaids want to implement it at the same time they are trying to implement all these other nine transactions.
It became, as Karen said, it was policy that it didn't fit the definition that exists in the final rule. In addition, NCPDP has gone through the process of making a subrogation of pay and chase implementation guide.
We didn't just put it out without much thought. It took several meetings, a lot of work. We had to do a lot of data modeling because there is quite a bit of difference between, I am submitting a claim from a provider to a payer versus a payer to payer transmission where you are actually turning around and paying the Medicaid.
We had to do a lot of data modeling to work that, and it works in 5-1, but has all that data modeling been done in X12 from an 837 to an 835, and I don't think it has.
MS. WARD: I think the bottom line on that one is that HCFA's interpretation of that is that the use of the guide for that purpose does not meet the use of the guide in the final rule.
So, the Medicaids that want to use it for that may still want to do it. The bottom line is that the answer didn't come from DSMO. The answer came from HCFA central office.
MS. GREENBERG: I am just wondering if they have a business need and how are they going to meet it.
MS. WEIKER: It exists today, Marjorie. They do it in a proprietary format. Some of them do it on paper, just because of the nature of the beast, so to speak.
MS. GREENBERG: They can still do that because it is not a HIPAA transaction.
MS. WARD: They can still do that. Technically, they can still use an 837 standard, just not the 837 implementation guide, and do that, if they want to do that.
DR. COHN: Richard, did you have a comment?
MR. LANDEN: Yes, it is Rich Landen speaking for X12N. The comments were accurate. When we looked at this as part of our piece of the DSMO process, initially it was proposed it is a coordination of benefits issue.
We really felt that it was not coordination of benefits, which is one of the specified HIPAA purposes. It fits better into a categorization called subrogation, which is not one of the HIPAA transactions specified.
When we looked, at X12N, at the solution proposed, it was overly simplistic, would have created other problems. As Margaret explained, NCPDP went through the process. X12 needs to go through the same process.
When we talk about subrogation, yes, it is critical for Medicaid, but subrogation is also an important process for the property and casualty insurance industry.
If we are going to do a subrogation component, either to the 837 or to one of the other X12 transactions, that is a bigger process than we can accommodate in this fast track time period.
MR. NAMINSCHON: I just want to add a bit to this discussion.
DR. COHN: Certainly.
MR. NAMINSCHON: The determination was that the subrogation transaction did not fall into any one of the four categories of HIPAA standard transactions. So, the Medicaid state agencies are basically free to use whatever it is that they want.
If they want to take an 837 and try to use that for subrogation, they can use that. No other payer is required to accept that transaction. So, that is number one.
Secondly, I think we have started talking to our Medicaid folks with the realization that we need to sit down with the X12 organization. The Medicaid folks need to explain their complete business need and work out a solution.
If that solution then is workable, we can, number one, adopt or determine that subrogation is a transaction that needs to be standardized, and adopt the appropriate implementation guide for that transaction. So, it is kind of a long-term process, but I think the first steps have been taken.
MS. WARD: A quick question about HHS and the NPRM process for this. Do you have to wait until all is said and done with our recommendation through the committee, through the committee's letter to the Secretary before you start drafting the NPRM? No? Okay. I am just trying to get a feel for it.
DR. COHN: They can't issue it, though, until we have a recommendation.
MR. NAMINSCHON: And we can't put it very far through the clearance process until we have the exact set of recommendations.
My guess is that we can sort of build the shell that says we have changes that need to be made, the background, the history of the DSMO process, and then there is this empty spot, here are the changes, and then the rest of it.
We can start building the shell and once we get the complete set of recommendations, we can build that in and put it through the clearance process.
MS. WARD: So, in a perfect world, what would your goal be to have this NPRM ready for publication? I understand there is so much that is not in your control, but I am back to the whole, you know, are we really going to get it out this fall.
MR. NAMINSCHON: Our goal is to have the final published by the middle of February. We will work back from that. That will meet the October deadline. We will have to sort of work back from that.
MS. TRUDELL: Can I say something? We will start drafting that reg next week.
MS. GREENBERG: Are we talking about one NPRM for all of this?
DR. COHN: Well, there will be an NPRM for the NDC, another NPRM for all of this.
DR. ZUBELDIA: Stanley, I think you can also fill in one of the holes, as to whether the recommendations are based on the A items.
DR. COHN: And I think we need to look quickly at the E items. There are only a couple more that we haven't talked about. Let's just sort of quickly zip through a couple of these.
I think we have talked about most of these already, one way or another, through our base conversations. Item 347, which is, I guess, a policy issue, it says here -- I think this was an issue having to do with, that people be able to basically use local codes, be able to develop their own local codes. I don't think this is something that we --
DR. ZUBELDIA: It was rejected.
DR. COHN: They rejected it. They said it was a policy issue. I don't think that this is something that we would want to second guess them on.
DR. ZUBELDIA: I don't see any action here for it.
DR. COHN: I agree. We could make a recommendation about something else to the Secretary, but that certainly was a major issue. 361, which I think is something we just talked about, which was the NCPDP, the batch --
MS. WEIKER: That is another change, to change the batch version from 1.0 to 1.1, which supports telecom version 5.1.
MR. NAMINSCHON: That is another NPRM that is currently going through the clearance process.
DR. COHN: Then the final one that I saw in terms of an E was 408, which is the --
MS. WEIKER: This has to do with Medicaids and encounters and the definition of an encounter. Stanley, to refresh you on this one, a managed care organization would send an encounter to a Medicaid. Is that covered under the final rule definition of an encounter.
In our discussions, the definition of an encounter was from a provider to a health plan, not a health plan to a health plan.
MR. NAMINSCHON: There will be an FAQ answer on that posted within the near future. So, we will clarify that.
MS. WARD: You are not going to tell us the answer, are you?
MS. WEIKER: He just did, Maria. She needs some more Diet Coke this morning.
DR. COHN: I think, with that, we have pretty well put together this particular discussion item. Are people comfortable with sort of the next steps, which are drafting of the letter, then the DSMOs complete their process, hearing from them soon about what items are coming up for appeal, and then understanding from them, as soon as possible, what the results of those appeals are, and then taking testimony from them, along with anyone else in the community that feels that they need to testify in June, with hopefully the idea of being able to bring something forward to the NCVHS at the June meeting.
MR. BLAIR: Question. Do we still feel like it would be appropriate for the NCVHS to make a recommendation related to whether the NPRM process is necessary? Is that your next topic?
DR. COHN: The next topic is general industry readiness issues, and I don't think that -- I don't know, maybe that is the final topic on this letter.
I sort of thought the general issue of expediting HHS processes was really the part of a more general letter. I guess as I would look at this, do people want to make a comment in this first letter about whether or not it needs to go through an NPRM?
My own personal feeling on this specific issue is that we ought not to make a recommendation.
MR. BLAIR: Let me just add one other thought to that, and then we will see whatever our committee decides to do. At least in my mind, the role of the NCVHS in terms of oversight, being broader than just oversight of the DSMO process, but even actually examining specific issues and appeals, seems to strengthen the idea that an NPRM might be redundant. I don't know what other people feel.
DR. COHN: Does anybody want to have this issue in the letter that we are sending to the Secretary? Does anybody have an opinion about this one?
DR. ZUBELDIA: I think that the AMA stated a clear position yesterday on that issue. I think that we probably ought to explore how to expedite the process.
I have seen some rules going through DHHS where the NPRM comes and a few months later there is a final rule. It doesn't have to take three years. It is not your fault.
MS. GREENBERG: Obviously, if we are talking about the final rule in February, it couldn't take that long.
DR. ZUBELDIA: So, how can we expedite the process as much as possible?
DR. COHN: Jeff, if it is okay, why don't we reflect on this in the next letter and see if there is something that we want to put back in this first piece.
I personally don't think that we gain anything by adding comments in this first letter about whether it should go through the NPRM process or not. I think what we are interested in is having this whole thing expedited, which I think is probably what your point is, and you are focusing on the NPRM piece as something to help expedite.
As Kepa is commenting, there are probably many other ways to expedite this whole thing.
MR. BLAIR: Karen, did we just lose you?
MS. TRUDELL: No, I am still here.
DR. MC DONALD: This is Clem. I will just listen in and catch up.
DR. COHN: Okay, the second letter that we are going to talk about -- Jeff, do you have a comment?
MR. BLAIR: I am just wondering whether we might solicit any comments from Karen or Clem on the topic that we are just discussing.
DR. COHN: Which topic? We are moving on to the second topic.
MR. BLAIR: To see if they support what you just said.
DR. COHN: Let's talk about this. I think we need to move to a second letter and then reflect back on whether or not this is a specific item we should dwell on.
There is a whole set of issues we heard about industry readiness, needing to get the final regs out, that I think the piece that you are describing is a piece of that, rather than as a specific piece having to do with this first letter.
At the end, we can reflect back on it and see if there is something that needs to be in the first letter. I think there are really two letters, one having to do specifically with what the DSMOs have recommended, and then there is a piece that has to do with general industry readiness, things that HHS needs to do to help with implementation.
I think you are sort of beginning to move into that item. At least, that would be my position. Is it okay if we move to the second letter?
MS. GREENBERG: Did you say that the first letter would include something about expediting this process or not?
DR. COHN: Not at this point, but let's reflect on that after we talk about what might be the second letter, and then we can reflect back on it and see if there is anything that needs to be in the first letter.
MS. GREENBERG: It just seems that if you are making some recommendations on this, you might make some recommendation related to implementing this.
DR. COHN: You mean that we should expedite publication of this revised rule?
MS. GREENBERG: Expedite moving this through the process, these changes that have now been recommended for the first year. That just seems to go with that.
DR. COHN: Stan, I think we would all support a sentence in there that says that. Jeffrey, are you comfortable with that as being a piece of the first letter?
MR. BLAIR: Yes.
DR. COHN: I am trying desperately to move us into the second thing on our list, and I am not being quite as successful as I would like to have been.
DR. COHN: Let me reflect on, I think, a number of items that I heard yesterday and that we somehow need to fashion into a letter. I am curious about sort of comments, suggestions or otherwise on the items.
Now, I have written down about eight issues here, which hopefully I will be able to read. Some of them are based on Karen Trudell's comments, but I think we all have different cuts on all of this stuff, and I am sure we all have others that I somehow did not capture.
Let me just propose at least a couple of items that at least I heard, that maybe are things that the Secretary needs to be considering.
Number one has to do that we need to get the final regs out, and that the Secretary needs to provide funding and, probably more important than funding, leadership to get the final regs out, the remaining final regulations.
What we heard yesterday is testimony -- there was not a single testifier who did not speak strongly for wanting to get all the regs out ASAP. That is item number one.
Item number two is -- I think I heard this one, although I may have come in sort of thinking it to begin with -- that there needed to be a consideration by HHS around what I would describe as an expedited change process, and truly to work with recommendations for changes to final rules that apply to all the HIPAA standards, both privacy and the administrative and financial transactions.
I think Marjorie, this sort of reflects on your comment about, well, geez, now that we have these changes, we want to get them out fast.
I don't know exactly what that process looks like, but I am aware personally that the same issue applies to the privacy final regs, that now they have been released, and yet the Secretary is trying to telegraph to the industry the fact that I think the Secretary already has changes they want to make.
MS. FYFFE: An expedited change process which is faster than that which is outlined in the HIPAA law?
DR. COHN: I think we are talking about the responsiveness of HHS internally. If we are going to talk about changing every year, we want to be able to have that change occur not from changes that were requested three years previously.
DR. ZUBELDIA: I think the law has the process for adoption of new standards. I don't think it has a process for changes.
DR. COHN: It says every year you can have changes.
MS. FYFFE: I guess my point is you have to change the law if you want anything more quickly. Is that what you are talking about?
DR. COHN: No, I am actually talking about -- I think we are talking about the example that we spent yesterday talking about, the DSMO process, where we have recommendations. How quickly can we get those out.
The fact is that we know that they can change once every year. They can certainly change less and they can take three years to make a change every year.
In other words, you could put changes in now but then get reflected in a final rule in the year 2004. That is what has been happening. If you think about it, that is sort of what has been happening so far.
MS. FYFFE: Now I understand what you are talking about.
DR. COHN: Are you in agreement with what I am describing?
MS. FYFFE: Absolutely.
MS. WARD: There is also the whole reason that we did this fast track thing is because there is this sort of out in the rule that says they can make changes within the first year.
Everybody knows how that is going to happen with transactions, but people don't know how that is necessarily going to happen with privacy.
I have even had people ask me, when I am talking about DSMO, raise their hand and say, well, can we enter changes for privacy into the change across system?
No, but the point is, people are saying, we get it, we know how to do this for transactions, but what do we do if we want to get changes made within the first year to the privacy rule.
It seems that a process that may look at, or not at all look like, but maybe a process to do that for other rules would be reasonable and maybe ease a little bit of confusion on the industry part.
DR. COHN: I think the Secretary has received some comments about changes to the privacy rule, about 20,000 of them.
I think the process is there. The question is, we need to have a process to have HHS respond quickly to them. At least, that is sort of my view of the big issues.
MR. NAMINSCHON: I do want to talk about a change process for changes to the standards, not necessarily the rules. I just wanted to make sure that is what you were talking about.
DR. COHN: I think both. I don't think you can do one without the other.
DR. ZUBELDIA: Even now we have some changes to the rules where we say the predetermination of benefits is the 837. That is a change to the rules, not to the standard.
DR. COHN: And the NDC is a change to the rule and not to the standard. Jeff?
MR. BLAIR: The HIPAA law seemed to have implied, if it wasn't explicit about the dates when each of these NPRMs would be issued, and there are understandable and valid reasons why we all haven't been able to meet those dates.
I think what we are hearing from the industry -- and I am trying to see whether the words I am about to offer would be useful and helpful -- I think that what we heard is that the testifiers almost uniformly are saying that they wish that HHS would have a greater sense of urgency to come closer -- obviously we are behind on the dates, but maybe it is a greater sense of urgency in getting the NPRMs and the final rules out. Are those useful words or not?
DR. COHN: I think they will relate to the first issue about needing to get the final rules out, and I agree with your wording.
DR. MC DONALD: I think, though, that those comments were all tied together by the few testifiers -- maybe it was two or three -- who also said they all had to be done at once. Those are absolutely completely impossible. You cannot do them all.
DR. COHN: Let's hold that other issue for later.
DR. MC DONALD: Just be careful that we aren't lured into a position that suggests that we think that is true.
MR. BLAIR: The law did not specify that they all be at once. I think if we stay with the law and just try to come as close as possible to meeting the requirements of the law, that we come close to what they are asking for.
DR. COHN: Jeff, it actually did say that they had to be out all at once. I don't think that it helps us to even go there or not.
Having said that, I think that the first point you were making is that there needs to be leadership by HHS to get these things expedited and get them out. I think, Jeff, that is what you are saying. I think we heard that from all the testifiers and I absolutely agree with your comment.
Obviously, that is one piece. The next piece we talked about was the expedited change management process within HHS to get changes out quickly to the regs, which is another piece of that.
Now, the third item I have here, this one sort of dips down in terms of priority. What we heard was, there was a desire and a request by industry to have continuity between the paper and the electronic formats; in other words, calling upon the Secretary to start providing for an update to the UB92 and the 1500 to provide increased comparability between the electronic and the paper format.
I heard that, I think, a number of times yesterday as something, once again, to help with implementation.
DR. ZUBELDIA: Simon, it is interesting on that topic, I have heard several times, not here, but sort of anecdotal evidence, people who talk to me about it, they do not want the paper formats updated. They want the paper formats to be obsolete, so that people will have to use the electronic transactions.
MR. COHN: Are you speaking as a member or are you speaking as the president of AFEHCT.
DR. ZUBELDIA: I am relating things I have heard in meetings.
MS. TRUDELL: Really, the paper formats are an industry issue. They are done by the NUBC and the NUCC. I am not sure that --
DR. COHN: Actually, Karen, my understanding of this one, and I will put my hat on as someone who is a member of the National Uniform Claims Committee, is that these things are done under agreement and contract with the Federal Government and that things have to be negotiated with the Federal Government, was my understanding, with HCFA and others.
MS. TRUDELL: The last time there was even attempt to redo the 1500, the industry people really had some significant problems with it and it was shelved.
DR. COHN: The industry, I think, is beginning to recognize, now that HIPAA is coming in, that there is need for these changes. I think the Secretary could provide some valuable leadership and assistance to make that happen.
MR. NAMINSCHON: You can actually take this a step further. I think we mentioned, in the final rule for electronic transactions, that the Secretary actually has the authority to set standards for paper transactions, but chooses at this time not to do it.
Our intention was to get the electronic transactions out there, see how the industry reacted to those, under the assumption that the industry would take it upon themselves to say, gee, these electronic transactions are standardized, we need to standardize the paper transactions.
I think we expected the industry -- the NUCC, the NUBC and others -- really to take the leadership to standardize these types of transactions.
MS. FYFFE: Is that a HIPAA authority?
MS. GREENBERG: You said that the Secretary has the authority to standardize --
MR. NAMINSCHON: Under the Health Insurance Portability and Accountability Act, administrative simplification provisions, the interpretation is the Secretary has the authority to set standards for paper transactions. That is how privacy was extended to non-electronic.
MS. GREENBERG: It would require the use of that paper standard by those who don't use the electronic standard?
MR. NAMINSCHON: To set standards for those who use paper transactions, yes.
MS. FYFFE: That interpretation, I believe, was stated in the preamble. It is not -- I am not an attorney -- it is not clearly stated in the law, but it is an interpretation that is stated in the preamble.
DR. COHN: I guess the question regarding this one is, do we want to make a comment about updating the paper forms. I don't mean this to be the focus of the next hour's conversation.
DR. ZUBELDIA: I think that the comment we have heard through testimony is people's concern of maintaining different identifiers for paper and for electronic, maintaining different code sets for paper and for electronic.
It is not for the paper form itself. I think the comment is more with the lack of ability to enforce the new identifiers on non-covered entities, and the new code sets on non-covered entities.
This is what I have heard from the payer side. A provider that is not covered by HIPAA because all they do is paper doesn't have to use the HIPAA identifiers.
DR. COHN: Well, we don't have any HIPAA identifiers.
DR. ZUBELDIA: We may not have any HIPAA identifiers, but that provider doesn't have to use the HIPAA identifiers. That provider does have to use the HIPAA code sets.
DR. COHN: Kepa, I think that there are a couple of different issues here. I mean, first of all, we don't have identifiers, so I think what you are describing is sort of a theoretic view.
We did hear Catherine Schulten talking about trying to deal with the 1500 in the world of the 837. I think she observed that there were some changes that either needed to be made to the form, or using the form in different ways, in other words, taking a box and using it for something else or redefining that box, which is basically the same thing as saying we need a new form.
I think there were some powerful observations, that them that exist in the paper world and them that are existing in taking the paper and scanning it into a transaction are going to have problems in the current environment. That is really what I was referencing at this point, and I think we did hear testimony on that point.
MS. FYFFE: I agree with what Kepa is saying and I think we would be remiss if we didn't keep this particular issue out in front.
We are going to have to keep bringing it up and bringing it up, but it is definitely an issue.
DR. COHN: So, redescribe the issue? We need to have it in the letter, first of all.
MS. FYFFE: There are two issues here. First of all, there was a fundamental -- this is my opinion -- there was a fundamental weakness in the law because it does not require providers to use electronic transactions. That is number one.
Then the second issue is the fact that, because of that and because of what was mentioned over the last day, of differences between identifiers, fundamental differences in terms of the information that is maintained by a provider that does both electronic and paper transactions and payers that have to cope with both, those are fundamental business implementation issues. There are really two issues here that I don't think we should lose track of.
DR. ZUBELDIA: I would like to say that there is a third issue. When you are talking about the desire to harmonize paper and electronic formats, I think that rather than harmonizing or redesigning the paper form itself, more than that, I think what would be useful is to have an implementation guide for the paper form.
The paper form, for instance, at the top has this box that says, this is a Medicare claim, Medicaid, Blue Cross, Champus, black lung or whatever.
Traditionally you would have put an X in the box. A new implementation guide more in line with HIPAA would put a P, S or T in that box, indicating there is primary, secondary or tertiary in that box. Nothing says you have to put an X in it.
So, the same form can be used without redesigning, and include a standard way of communicating those extra elements that the ASPIRE project has identified.
It could be that we reserve a place in the form that is even unmarked, or one of the boxes that says reserved for local use, to convey the provider taxonomy.
Some simple implementation guidelines of the existing paper form could take care of that.
MS. WARD: Speaking from participating in the NUCC, after we went out and we held these focus groups and we asked people about their ideas for revising the HCFA 1500, the response to that was that those surveyed felt that that was not the right thing to do, but the response was to draft a guideline or an implementation guideline on how to properly fill out the HCFA 1500 form. That is the position the NUCC was taking after having done that survey. I think that is a reasonable approach.
I don't know if we ever got there or how far along we are, but that was what seemed to be the approach the NUCC was going to take with the 1500.
MS. WEIKER: My comment is, don't forget the dental claim form, the ADA form. I mean, you have got an 837 implementation guide and an ADA form, and they won't match either.
MR. LANDEN: I get to wear my Blue Cross Blue Shield Association hat for a change. One of the questions that we as an organization have is what is the value of maintaining a paper standard in a post-HIPAA world.
Obviously, there are some strategic discussions. George mentioned yesterday the UB has a 10-year moratorium and that moratorium ends next year.
So, next year, normally in our 10-year cycle, would be the time we would need, again, the redesign of the UB.
As Maria and some others mentioned, we looked a year or so ago at redesigning the 1500. The issue that was raised before, maybe we, as a strategic incentive to use the HIPAA electronic standards, should not put effort into keeping the paper forms in synch with the electronic forms.
From my own perspective, though, I don't know the answer to the question on behalf of the Blue Cross and Blue Shield plans.
What is the trade off between the value of having a standard paper form in a HIPAA world versus the resources it takes us all collectively to maintain a paper standard form.
DR. COHN: I guess as one who is older than I like to think sometimes and proclaiming the world of clinical information systems and paperless medical records back in the early 1990s and late 1980s also -- and I know Dr. McDonald probably shares some of this long-term vision that I have, but recognizing that in the year 2001, most of us might observe that we haven't quite gotten there, nor have we gotten to the world of complete electronic commerce for all claims and other activities.
Probably one needs to observe that one needs to provide for transition. I guess the question is, would having continuity in data elements and/or implementation guides or otherwise, between the paper version and an electronic version of a claim be something that would be helpful to the industry.
My observation is that I heard that a couple of times yesterday and basically agree with it. I think we have all seen that there needs to be some way to transition, that you don't just pull plugs on people, especially when you are dealing with claims and otherwise. I may be overstating a personal bias on this one. This is sort of my view, I guess, learned through the school of hard knocks over many years.
DR. ZUBELDIA: I think that is very, very important, to have the ability to transition. I think we also need to be cautious as to what is fitted into the paper form.
Over the years, a lot of things have fallen into the 837 electronic form that go way beyond the scope of a 1500 or a UB92.
For instance, the 837 has certification records and it has the DME certificate of medical necessary. All these things that are attachments to a paper form today on a separate form have become part of the 837.
I would take the 837 as the model and try to fit all of it back onto a 1500 form. It is going to overflow. We won't have enough space on one sheet of paper to do it.
We need to be cautious, when we do the retrofitting of the 1500 form or the UB92 form to fit the 837, to remember that the 837 has multiple forms built in.
DR. COHN: This is something that I really don't want us to micromanage. I think the question is whether or not we want to suggest to the Secretary that there needs to be some continuity, recognizing that there are probably a lot of experts that we heard from yesterday and people outside of this room, who I think understand very well the issues that you are describing, and people like Catherine Schulten who have obviously put a lot of thought into this stuff.
Is this something that we want to support in terms of a bullet point to the Secretary?
DR. ZUBELDIA: I would support the recommendation to NUCC and NUBC that they look at an implementation guideline for the paper form that is aligned with the HIPAA data requirements.
DR. COHN: Are we comfortable with this one so that we can move on to the next item? I actually withdrew some controversial items, only because I thought this one was less controversial. I am afraid that is going to be the next pieces.
The next item, I am just sort of running through the items, if there are things that we are missing or otherwise.
DR. COHN: Another major issue -- and maybe we had set up these panels to really expose it, and this is, I think, what Jeff was beginning to comment on as well as Clem, but there are major issues about the Secretary taking leadership to provide an orderly successful implementation of HIPAA.
Part of that is things we have already talked about. There is the issue of regulatory flexibility, potentially.
I don't know whether it is within the Secretary's charge or not, but there is the issue potentially of some flexibility in relationship to a modest delay, a fixed delay.
I think that we all sort of came away feeling that there were many problems related to what I will describe as an indeterminant delay.
Certainly -- and maybe I am speaking of things that I have heard outside of this room -- I really heard a lot of people from industry talking about having a predictable set of dates for implementation to shoot for.
Again, what I am hearing from the industry is that they are in absolute consternation because of uncertainties coming from HHS in relationship to dates of implementations of things, various other things that are causing them to turn on again, off again their projects related to HIPAA implementation.
I think the Secretary maybe needs to take some leadership in terms of giving the industry some guidance around that.
I think there is also a piece that I think Kepa brought up yesterday, which is that HHS needs to make maximally available to the industry the current thoughts, even if they aren't in final rules yet, about what the future regs are going to be requiring.
This goes all the way from how many digits is going to be the NPI, if indeed that is known internally but just hasn't gotten out into a final rule, to if there are significant changes that are likely to be coming on security, and on and on.
Now, I think it is unrealistic to expect people to make promises on the basis of an NPRM. Once things have gone through an NPRM process and are being dealt with internally, I think to help ensure implementation, people need to know.
Anyway, comments about that one, that one I expect to be controversial. People making comments? Come on.
MS. BEEBEE: What is so controversial? You are stating the obvious.
DR. ZUBELDIA: It is clear, and I think HCFA, for instance, is providing clear leadership by instructing their carriers to be in compliance by October of this year.
They are going to be the first ones in the market to be in compliance. Sure, there could be more things done. Having white papers on these future rules and what the current thinking is could be important.
We recognize, for instance, that the industry, as far as security is concerned, has changed since the proposed rule came out.
It has been a long time and the industry is changing, so what is the current thinking? It would be useful, definitely.
DR. COHN: What about enforcement flexibility?
MS. BEEBEE: I was going to ask you, how is this different from your first one, which you talked about. Another issue, does this get down to just not the leadership but the commitment.
Some of the things that we talked about yesterday was the lack of resources within HHS and the other agencies that are responsible, where we are working on privacy one day and security another. Does that play into any of this?
DR. COHN: It may mean that this one and the very first one we talked about are really parts of the same thing, and it may be that we are just talking about a whole set of different bullet items, about how the Secretary can provide leadership.
Certainly, in the first area, we said there needed to be adequate funding to make things happen. Maybe that applies to both getting the HIPAA out and getting this thing implemented. I certainly wouldn't argue with that comment. Bill, do you have a comment?
DR. BRAITHWAITE: I think they are different points in the sense that the industry needs these things out quickly and some detail about what they need to make progress would be important.
I think that is different from the resources and funding issue a little bit because, in one case, the industry is asking for sort of prior knowledge about what is going to happen, letters from the Secretary, white papers, whatever, that reveal the decisions made about the NPI, for example, before the NPRM comes out, or maybe put the standard for the identifier out before you figure out how to actually implement it.
Stuff like that is a different cut on the communication between the Secretary and the industry. That is different from put some more resources into getting stuff out faster.
MR. BLAIR: I guess that this is just a personal opinion I am expressing now and it might change based on discussion or other factors.
I think of this as three basic positions that we might consider taking on our committee. I think that one position that we could take is to reflect the priorities that we heard.
I think we clearly heard priorities to try to get the data security regs and the national provider identifier out as soon as possible.
I think that those two should be recognized as on the top of the priority list, that that will help somewhat.
Number two, I think I also heard that, whatever happens, we don't want to do things that would undermine all of the elements of the industry that are working very hard to move forward, by either creating a condition or situation which would promote people from stepping back from the sense of urgency about moving forward.
For that reason, I think that it might be well if the NCVHS took a position that it is premature at this point for us to wind up indicating any type of a delay.
However, the third point is that there should be recognition for the fact that there are either different transactions, code sets or portions of the industry -- segments of the industry -- which may have difficulty meeting the final dates for compliance and that, as that date approaches, it may be appropriate for the NCVHS to monitor the progress of the industry, giving special attention to those who have really given best efforts to try to move forward, not delay it, but those who have given best efforts.
If we see at that time -- which may be nine months or a year from now or something like that -- as we approach the compliance deadline and we wind up seeing that certain portions of the industry or certain specific transactions need additional time, that we could selectively make those recommendations at that time.
DR. BRAITHWAITE: Jeff, I like that sentiment, but what I heard in the testimony would contradict that. That is, the industry is saying they need a date certain and it has to be that way because, if everybody is not ready at the same time to do at least an identified subset of transactions, then they are going to have to run two or three or four systems, information systems, to process the different forms of things that come from different people.
Rather than kind of waiting until the last minute and then saying, well, it looks like everybody is not ready, so let's delay another year or two before compliance is required, that kind of recommendation leaves people stuck with, well, they are probably going to delay it anyway, so let's not do anything about it for a while and see what happens.
If a more structured or even phased implementation plan were recommended, something along the lines of what Kepa was talking about yesterday, some of the things that were talked about were, for example, in general, it sounded like the industry did not have enough time to get ready as a whole.
There were a few subsets that could be ready by October of next year, but it seemed like the majority of them needed, let's say, an extra year to be ready, and then some specified transition time, after everybody was ready, some transition time for people to kind of gear up and make their trading partners tested and compliant and all that sort of stuff, which may take another six months or a year, that the industry in general would feel more comfortable -- this is my impression from the testimony in general -- having a fixed date where everybody must be ready or be out of compliance with federal law, and then a more flexible implementation period after that with a fixed ending, rather than just kind of playing it by ear as we go forward.
MR. BLAIR: Let me see if I could blend my thoughts with yours a little bit. Putting things in phases, I think, makes a lot of sense. However, I am not -- there are two pieces to that.
Number one, I think that we would have to learn more. I don't think we are prepared to identify the phases at this time.
The other piece is that it is not clear to me that the entire industry may need delays. So, there may be segments of the industry, segments could either be the providers, the payers and the clearinghouses -- those are three segments -- but I am also thinking of the fact that many larger providers, for example, may have the capability of getting there, but rural hospitals or solo or group practices may need a longer time.
So, my thought is that we can begin to look at those. The only pieces that I am worried about is that we take the position that we are looking at delays on a wholesale basis, that that would discourage those folks that are putting forward the budgets now. It is almost like a self-fulfilling prophesy.
I would rather us take a position where we wind up saying we monitor the progress and see where the delays are needed.
DR. ZUBELDIA: Jeff, I think that is a very good point. I failed to hear yesterday, from the people who are asking for a delay, what the delay is for.
Do they need more time for identifiers? Do they need more time for code sets? Do they need more time for specific transactions like referrals? What is it they need more time for?
They were saying, we need more time without a reason for the more time, other than we are not ready yet.
The AMA said that the providers are behind the curve and they are not ready. On the other hand, they said they are not doing anything to make the providers ready, which was kind of shocking to me.
How can you say you want more time when you are saying you are not doing anything to help your providers?
MR. BLAIR: Exactly.
DR. ZUBELDIA: I realize also that 99 percent -- this is my guess -- that 99 percent of the AMA members will not implement HIPAA themselves. They will rely on their vendor.
In general, it is not up to the provider to do the programming in their systems. There are some exceptions, some crazy people who work with computers.
So, I think in that area, on the provider side, whether the AMA says the providers are ready or not, is not as important as on the payer side and the vendor side. The payers will be doing this themselves with consultants and vendors, but mostly by themselves. So, it is important to listen to them.
On the payer side, when Harry was talking about what he would do as a payer, not as representing the Association, if he had more time he said, I would reorganize my packages and implement my packages in a different order.
That is interesting because that means he is not going to implement it all at once. Although he can't admit it in public, he is actually looking at implementing it in stages.
Those are a couple of observations from yesterday. It was interesting that we still don't know why they need more time, what are they going to do with the more time, other than delay the whole thing.
DR. BRAITHWAITE: I did hear one person say why they needed more time, and this seems to be true of several payers that I have heard and have heard about elsewhere.
Over the years, they have depended upon, for adjudication of the various contracts that they have let, the provider providing information in such a way that they don't have to change their adjudication system.
So, they have special local codes and they have identifiers that have intelligence in them, as we have termed it.
So, not only does it identify the provider, but it identifies the contractor providing the care under the location they are providing the care at and all kinds of other stuff, and their business process of adjudication is dependent upon those internal intelligences that come in as part of the coding system.
In the standards, we have taken away that intelligence, which means that they have to redevelop their adjudicating processing to get the necessary information in other ways from other information in the claim or from data bases they already hold.
That business reengineering is what, I think, causing them to say we need more time. Then there are the other payers who are saying, rather than putting an EDI wrapper around our legacy system, we are just going to replace the whole thing because we see the writing on the wall. We need a new system because all of this intelligence is going to go away.
I think there are two things they are saying to us. Some of them, at least, are saying, we need to know what the identifier standards are.
It is not because they need to know what the identifier standards are because the standard transaction already contains the instructions about what to do with the old identifiers and what to do with the new ones.
It is because they need to know how to reengineer their processing behind those identifiers. If we can't put out the identifiers because we can't fund the actual assignment of the identifiers, maybe the concept that came up from one of them of splitting the idea to say, here is the identifier that we will be implementing, given that that will give them more time to implement the adjudication process behind it before it becomes a requirement to change the identifier.
There are some phases of that type that you touched on yesterday which I think could be very powerful to help the industry comply in a relatively rapid way, but staged according to the major changes that have to be made. I don't know if that makes sense to anyone else, but that is what I heard.
DR. ZUBELDIA: Another identifier related point that Harry brought up is, when you start issuing the NPI, I want you to require all the providers to get an NPI within three months, so I don't have to be deploying a parallel system for two years.
I want you to issue the NPIs quickly. I think that is another of the leadership positions that the department can take.
MS. GREENBERG: Just following up on what Bill said, another reason that I heard -- I don't know whether the state Medicaid directors, have they taken an official position on delay, I think they have -- but the issue that Sally raised that -- I don't know how many states this is, but having a legislature that meets once every two or three years, and there is literally no opportunity to get funding to implement in time.
I don't know how many states have that problem, but that is a different type of problem than other private sector payers might have.
I have a question that everyone may know the answer to. Has the department taken an official position on the legislation that has been introduced on delay?
MS. TRUDELL: No, it hasn't.
DR. COHN: Can the department take a position on legislation?
MS. GREENBERG: Yes, the department is routinely asked its position on legislation.
DR. COHN: Let's get very specific here, then, for a second, because I think the question gets to be -- I didn't realize that we could recommend to the Secretary, legislative positions or whatever, but I think that becomes very helpful.
First of all, there are things that Jeff said that I very much agree with, which is that we don't want to start providing any signals to the industry or provide incentives for people to slow down, because it really is a self-defeating prophesy in many ways.
On the other hand, I am struggling with the fact that this is a big thing and 18 months is not a long time from now to do implementation.
I think there are a couple of things that I think we are all sort of in agreement with, and let me just posit a couple of opinions that the Secretary might use in terms of as they begin to think about the idea of, if there is any delay to be considered.
One is that I doubt that there is anybody on the subcommittee that is in favor of what I would describe as an indeterminant delay. If I am wrong about that, please raise your hand and let me know about this one.
I think we need to make a very strong statement about the concept of indeterminant as opposed to determined delay, a fixed delay. That is number one, the indeterminant delay issue.
Number two, at least to people I have talked to in the industry, there is the issue of modest delay versus prolonged delay. I think we are in favor of things that ensure an orderly, successful implementation, and I think that is our number one item here, and we don't want to have a delay that is so long that it encourages those that have started working and that have put their projects together and are moving forward, to disassemble their projects and then have to start up again.
Certainly a long delay, even if it is fixed, has a very serious potential to do that. So, the question is, how long of a delay gives people enough time to do it in an orderly successful way while, at the same time, not encouraging them to just sort of stop for another year or two and then start up again in a year or two.
Once again, this may be my own personal opinion, but I certainly had the sense that a year's delay may not be a bad length of time if one is talking about a delay. If you get much longer than that, and you get into this issue of, well, I won't start or I will slow down this project for a while or lay off half my people or whatever.
So, if we are talking about a fixed delay, I would suggest that we are talking about a modest fixed delay, once again, to encourage successful, orderly implementation.
I think on top of that there may need to be, as I think Jeff was describing, some regulatory flexibility on implementation. Maybe that occurs as a piece of this.
Jeff commented about small and rural providers. I observed, of course, that yesterday we had the big providers in talking about how they couldn't implement it. It is hard to know who is going to have trouble but it certainly may be that, as we move forward to this, there needs to be some observation about really who is having trouble and the Secretary may need a little bit of flexibility, but not in any way to discourage implementation.
MS. GREENBERG: Small providers already have an extra years.
MS. WEIKER: Small providers, small health plans.
DR. COHN: Providers have an option.
MR. BLAIR: There is one piece that I have to confess colors the way I am reacting to some of the testimony, is that there are a number of folks who have testified that have really been very proactive in the process.
They have made investments. They have gone forward. They have participated in the coordination in WEDI SNIP. When those folks wind up indicating they are having difficulties, to me, that has a great deal of credibility.
I feel like we really need to very seriously consider giving those folks relief when they say that they need relief.
I don't have as much -- I am not influenced as much by those who haven't started the process, who wind up saying they want delays.
My thought is that we need more time before we can wind up crafting who is entitled to delays and how much that delay should be.
My thought is that we really should give greater emphasis to those folks who have started the process and worked through the process and then tell us where they are having problems, as opposed to those who have held back and are just asking for delays.
MS. WARD: A comment, and I am going to share with you a real world example that some of the payers -- at least one payer in particular that I have been talking to -- is experiencing.
Today, right now, they have two possibilities for strategy with EDI. One says, I have this old, you know, beater system that processes that many claims. By the way, I am also installing a new managed care system right now.
I can get that managed care vendor to handle my indemnity business for HIPAA if I have another year, and I am right in the middle of that implementation right now, or I can figure out a way to wrap around my old existing legacy system and deal with it.
Even if they can, they think that the strain that that will have on that system, even if they create a wrap around, might make it impossible.
Speaking to the date certain thing, if we were to come out of the gate and say, here is the date we are recommending for a delay, the strategy decision that they are trying to make today and have been trying to make for three months would be made for them.
I would recommend to you something that I recommended yesterday that follows sort of the WEDI HIPAA success task force approach that says, don't just give a delay and give it a date. Give it deliverables, give it requirements.
We are not just going to push it out two years. We are going to say, okay, maybe it gets pushed out a year, but October 16, 2002, here is the set of things that you have to be able to demonstrate.
Then maybe a year later, you need to now have moved farther along the path. That is the piece that speaks to HIPAA program offices not losing their budgets next year that they have already got. Half of them are starting to lose them already because of just the threat of delay.
They need to have dates and they need to have goals and requirements or you are going to lose that motivation and you are going to lose that steam.
It has been my experience, do I think that most of the people I work with will be 100 percent converted within two years, or in October 2002? No.
Do I think most of them need more than that other year? Probably not. I think a year wouldn't make a world of difference to a lot of them.
DR. COHN: So, what you are describing is the concept of an extension, but deliverables actually in 2002 that are somehow required and not just sort of saying everything gets held off.
MS. WARD: That is what the WEDI recommendation to the Secretary said.
DR. ZUBELDIA: I would like to make a couple of observations. There is a group of payers that is going to be ready in October of this year, not October 16, October 1 of this year, a year ahead of schedule.
Those are the Medicare carriers. One of the reasons why they are going to be ready is because HCFA made the decision early in the game to not change the adjudication system, implement EDI with a translator and don't change the adjudication system. Do whatever it takes to implement it without changing adjudication.
That has made the process much simpler for them to the point that they are going to be ready this year.
Now, the other contingent that is ready is actually now -- at least they claim to be ready now -- is the clearinghouses, because the clearinghouses don't have an adjudication system. All they are doing is the EDI part of it. They have one the EDI translator and mapping and they claim to be ready.
It seems to me like the EDI part, as long as you don't change the adjudication system and it doesn't have repercussions in the rest of your business, is feasible within the two-year time frame.
What is complicating the matter is that, besides the EDI, you have to change the identifiers, the code sets, the business rules behind it, the business rules in your adjudication system.
It gets so complicated to the point where some people consider just replacing the system. Some people may be able to replace the system with an extra year. Some people may need two years, some people may need four or five years to replace the system.
There is no way to accommodate all the people who are going to replace the system within a time frame. If we are looking at getting real deliveries right away, I think the EDI part is deliverable immediately.
The identifiers and the code sets are the ones that are creating the problems. Within those, it seems like there are two parts that we are hearing a lot about, and that is the taxonomy codes and the removal of the local codes.
Maybe as part of the deliverables that WEDI is talking about, we can group them in those groupings and see if there are scheduled deliveries.
Given that the NPRM for the payer ID has not come out and the final rule for the NPI has not come out, it seems to me that we have already built into the system, because the final rules are being delayed, built into the system that schedule of delivery.
If we stick with the dates that we have today for the parts that we have today, the problem is solved, except potentially for local codes and taxonomy codes. Maybe those need to be retracted just as the NDC was changed. I don't know, but that may be a recommendation, to maybe continue with local codes for a certain amount of time and continue with specialty codes or not even use it for a certain amount of time, that taxonomy code.
I think we already have built into the system the scheduled deliveries, or maybe unscheduled phased deliveries of the final rules.
That is essentially what a lot of the comments to the initial transaction and code set NPRM said. A lot of the commenters to the initial NPRM were requesting a phased approach, rather than trying to do everything at once.
MS. GREENBERG: I agree with Kepa, that in a sense there is a delay built into the identifiers, because if they are not there, you can't use them, and yet you can implement without them. I mean, it is preferable to have them, but you can implement without them.
DR. ZUBELDIA: You can. You are doing it now.
MS. GREENBERG: So, that is built in. I guess on the codes, I have really been impressed with Medicaid, what they have done with the local codes.
HIPAA got them to do that in a way that nothing else ever could have. I still think the highlight of my year, almost, was when I heard Sally Klein say, at the Public Health Data Standards Consortium steering committee meeting that, you have always heard that if you have seen one state Medicaid agency you have seen one state Medicaid agency, and they have discovered that isn't true.
This has really brought them together. I would hate to discourage that. They have made phenomenal progress on the local codes.
I don't know the extent to which the HCPCS process can accommodate their requests, but I am sure HCFA is going to make every effort to do so.
I also don't know, but if Medicaid, which is 50 different states and maybe Guam and I don't know who else can do this, I am not convinced that Blue Cross can't figure out what to do about local codes.
I know the taxonomy is a big issue and I don't know how that is going to come out on the appeals process. I guess just in line with what Jeff has been saying about not discouraging activities that are underway, this has been so impressive, that I would hate to discourage that in any way, what they have done with local codes.
DR> ZUBELDIA: Could I make a comment on Blue Cross Blue Shield I am sure we will hear from Rich Landen? It is interesting to see how a lot of the Medicaid carriers and intermediaries that are going to be ready this year by October 1 are Blue Cross and Blue Shield plans.
It is interesting to hear them say we can't do it, we don't have enough time. You know that their Medicare side of the house, which is not the same as commercial, is going to be ready. That is interesting.
Now, on the local codes, the Medicaid has made a lot of progress and I am really impressed by going from 30,000 codes to 600 codes, except that nobody else outside of the Medicaid work groups knows what those 600 codes are.
It would be great if the rest of the commercial payers would have access to that information, so they can start looking at what their systems need to do.
MS. WARD: They have offered that to our work group in HL7.
DR. COHN: I want to let Rich make a comment and then I want to bring everybody back to reality. We are not going to solve people with our own good ideas in a subcommittee of the NCVHS.
Rich, do you want to make a brief comment and then I am going to try to bring everybody back.
MR. LANDEN: Obviously, my organization supports something that is not quite date fixed and not quite indeterminant, but we have got reasons for that.
I saw a lot of heads nodding when the discussion here was that the standards are designed to use existing identifiers. That is true.
I point you back to what Harry Reynolds from North Carolina was saying yesterday. It is more the business process changes behind the systems.
In one of my spare time activities, I co-chair the WEDI policy advisory group on the identifiers. For the NPI, which is the one which is ready to go, we don't have any commitment that we know of, of how that system is going to be funded.
So, we know kind of what the identifier is going to look like, but we have got three possibilities, including the range between each of the three nodes there.
The first possibility is that, as designed, each provider will have one, maybe two, identifiers, which is similar to the way Medicare works today, where each provider has one and only one identifier, and very dissimilar from the way a lot of the private sector managed care contracting world works. That is one possibility there.
The other possibility is more along the lines of the existing system that some of the industry, and certainly some of the blues -- not all the blues -- assign an identifier for each contract they have with a given provider.
The NPI, as we have discussed it -- and of course we don't have a final rule -- the recommendation from WEDI was to allow the provider to allow the provider to request as many NPIs as he, she or it felt it needed for its business purposes.
So, we may have providers with many, many NPIs. That is the discussion. Again, we don't have a final rule.
The third possibility that industry implementers are looking at is the possibility that we will not solve the funding problem and we will never ever have an NPI in our lifetime.
These are the business issues that the blue plans and others are worrying about when they are designing their implementation strategy, when they are designing their system architecture, when they do the, do we refurbish what we have got or do we buy a new system.
It is not a simple question of, well, the system works with existing identifiers, because we are not going to have the same system when it comes to implementation.
These are some of the reasons that my association's position is, we need this stuff as a package and that the sequential or piecemeal implementation doesn't work for a lot of the industry.
DR. ZUBELDIA: May I make a comment?
DR. COHN: You can make a comment and then we have to get back to reality.
DR. ZUBELDIA: I think this is a real comment. When we are looking at which standards to adopt under HIPAA, we are looking at the NSF and the UB92 and the X12 standards.
One of the arguments for choosing the X12 standards was that these standards can be implemented with a translator. Studying the translator isolates the communication standard from the legacy system behind the translator and the system that they have behind it.
I think that most payers are installing translators and will be installing translators to accommodate the standards, at least the X12 standards.
What we are seeing now is a request to get a delay to change the back end system. It is not to do the translator part, it is not to do the EDI part.
They are saying, wait a minute, if I am going to do this, I am going to change my back end system. Give me enough time to change my entire system.
We are going away from the translator concept that makes the back end system transparent and the EDI independent of the back end. We are tying both of them together.
I know there are perfectly good business reasons to do that, but does everybody need more time to change the back end system, or can they install a translator today and then change their back end system at their leisure, as long as they don't have issues and requirements in the translator that require them to change the back end system.
DR. COHN: I hear we need a five-minute break.
MS. GREENBERG: I have an alternative proposal, a little longer than five minutes. I assume then we would just go until we end. So, if anybody wanted to grab something from downstairs, that would allow them to do it, unless we are going to be done by 12:30.
DR. COHN: We are going to be done by 12:30. So, five minutes.
[Brief recess.]
DR. COHN: I think there has been a suggestion, which I really want to bring up at this point, rather than trying to conclude this particular conversation, and try to find an answer or solution for the industry around all these issues around implementation and all that.
We take the comments that have been made so far, try to craft them into a possible draft for us to consider further, but that we actually have a meeting the day before the full NCVHS meeting, which would be June 26, to further discuss what recommendations we want to make to the Secretary and want to bring forward to the NCVHS at their meeting on the 27th and 28th, as well as discuss the issues coming forward from the DSMO appeals process at that point.
I do understand that I think Marjorie and NCVHS staffer will try to arrange a room for that. I think tentatively it would make sense for us to reserve that date and just plan to have what is effectively a full day meeting that day. I think if we are going to be here, we might as well.
MS. BEEBEE: Let people fly in on the morning of the 26th, if that is feasible.
DR. COHN: It is not feasible for myself and not feasible for Kepa. It could be feasible for Clem, if he is going to be here and Ted Shortliffe, I am sure.
I think Kepa's earliest flight would get in at 2:30 in the afternoon to the airport, which isn't going to help us too much, and the same situation is true for Jeff.
MR. BLAIR: I can get here by 2:00. I can't get here earlier than 2:00.
DR. COHN: We could plan to start somewhere between 9:00 and 10:00, depending on who is going to be flying in that morning.
MS. GREENBERG: Excuse me, but there would be no testimony or anything like that?
DR. COHN: We would be asking to have the DSMOs potentially either come in person or call in to talk about their recommendations. I think that is testimony.
MS. GREENBERG: I am thinking in terms of staffing it, since we have the full committee meeting. If we are not going to have to be copying a lot of stuff, we can have just one staff person.
MR. BLAIR: If we have the DSMOs, it would be the opportunity, or should be the opportunity for anyone in the public to make their statement about the DSMO concerns.
DR. COHN: We won't pre-arrange panels, I think, is the issue.
MS. BEEBEE: The full meeting in June is not at the Humphrey Building.
MS. GREENBERG: No, it is at the Renaissance Hotel.
MS. FYFFE: The full meeting in June is at the Renaissance Hotel in the District. So, would we be meeting on the 26th here?
MS. GREENBERG: We have to look into that. We got the hotel because we couldn't get the room here. If we can't get a room here for the 26th, the logical thing would be to try to get a room at the hotel.
DR. COHN: Is this agreeable to the members of the subcommittee, what we are proposing?
I guess before we leave this topic, we obviously have gotten sort of, I wouldn't say stuck on this particular issue, but are there any other issues that would need to be represented for us to rough draft a set of comments to the Secretary?
The only other piece that I heard had to do with the issue that people thought it would be desirable for there to be testing of new standards to be implemented. I don't know whether that becomes part of our recommendation. I think there are already in the law or the regs procedures to test standards and get dispensations to test new standards. I don't know if we need to do more on that.
DR. ZUBELDIA: In the law there is a procedure for testing new standards to be adopted by the Secretary as replacements of existing standards.
We are talking about testing new standards that are not replacing anything before they are adopted. I am not sure there are procedures for that.
There is a requirement that the DSMOs do a certain level of testing and the preamble on the transactions and code sets final rule discusses the kind of testing that DSMOs are supposed to do. I think that is all it says about it.
DR. COHN: Is this issue at the same level as the other issues we have been describing? My only concern at this point is that we don't want to start diluting a letter with a whole bunch of bullets that are not at quite the same gravity as the things we have been talking about it. So, we will defer that discussion.
MS. GREENBERG: The committee indicated that we should make sure that any proposed standard is out in the community and preferred to be in national use before it is adopted as a national standard, de facto standard approach.
Actually, given the HIPAA process, something can't be in national use unless it has been adopted.
DR. COHN: I wasn't bringing that forward as a recommendation.
DR. ZUBELDIA: For instance, if the prescriptions become a national de facto standard, then it could later be adopted as a standard by the Secretary.
Because prescriptions is not part of the nine named standards, they are free to use anything they want. The same thing for the standard that X12 has put together for two payers talking to each other to identify previous payment on a claim is not one of the named standards. So, that could be adopted as a national standard. I think that is what that paragraph is referring to.
MS. WEIKER: I have a very brief comment, Simon. It is about what we were talking about before the break and what we are talking about now.
Yesterday, we heard a lot about why I can't do it, but we didn't hear a lot of why I am doing it. As Kepa said, there is somebody who is going to be ready October 1.
I know UHEN is ready now. I will have health plans ready. Before this committee starts drafting possible delays, maybe you should get how come we can implement it where some can't.
Maybe there are best practices or best something to be learned and adopted instead of just why I can't. Why not hear, why I can. That is just my comment. I didn't hear that yesterday.
MS. BEEBEE: You are here now. Do you have a reason why you can?
MS. WEIKER: Basically it goes back to, analysis has been completed with the transaction sets and it has gone into the actual claim adjudication systems.
We have looked at, for example, in some of the Medicaids, you don't have type of service any more. How do you then take the data elements that you will have in the guides and the transactions and replace that.
In many cases, it is okay, I can take these two data elements and make that determination. It is not a big change, but yet, it is a change.
The local code issues -- and Marjorie and Kathleen and several people have mentioned what a phenomenal job Medicaid is doing.
Well, Medicaid probably needs to share that, how they are doing it, what the list is, those type of things. Will they all get done by the October 2002 date? There are some who are wavering with, we have so many that we are not sure we are going to get it all done, but all we need is one more month versus one more year or two more years or three more years.
Bart Kallean(?) with UHEN, I am sure, can come up with reason after reason with why. The National Provider Identifier, a lot of the systems we run, the length of them are six digits.
Well, we made the assumption that it was going to be 10 and if it turned out being eight, well, we had two extra bites.
We made that assumption and we said, we can still use our identifiers today, so the transaction is allowed, so we are going to go forward.
We know in the future that those smart numbers that we have today are going to go away. How can we replace them? Taxonomy, and that is required.
It is going down and looking at, where are my gaps and can they be filled. So far, the majority of them can be filled.
Yes, there are going to be some replacement systems, but some of those systems needed to be replaced in the first place. They are held together with band-aids and paper clips as it is today, and any kind of minor change would cause a big problem.
DR. COHN: Okay, thank you for your comments. I actually don't think we are going to come to resolution on this particular issue today, as I commented, but I think we do need to reflect a little bit on all the testimony.
I would certainly encourage everyone -- we had a lot of testimony yesterday from a lot of major industrial players.
I would suggest that probably, if we are going to indeed discuss this later in June, it would behoove everyone to review that testimony carefully.
We did hear a wide variety of comments representing more than just one particular vendor or player or provider in the marketplace. So, certainly I think that would make sense. I actually want to move on to some other issues.
DR. ZUBELDIA: I think Margaret is right. I think we need to hear more HIPAA success stories than HIPAA lack of success stories or lack of progress stories. We need to hear more HIPAA success stories and maybe HCFA can tell us how come they can do it, what do they do differently.
Some of the clearinghouses are doing it. UHEN is doing it. Maybe we can hear some of those success stories and see if we learn something from that.
MR. BLAIR: I had somebody approach me recently, a vendor, who ended up saying that they have successfully implemented it with payers and providers saying the same thing, listening to the people who are asking for delays. They felt like they would like to be heard also.
MS. GREENBERG: Do you want to try to hear from some of these people in June?
DR. COHN: I guess I am sort of struggling a little bit, only because I think WEDI probably has a better sense than anybody about successes, and we did hear testimony from them yesterday.
DR. ZUBELDIA: At Claredi, we are getting ready to certify several thousand providers as HIPAA compliant, out of the clearinghouse.
It is relatively easy to be compliant with the transactions. It is all those other business issues that sometimes get in the way.
DR. COHN: This is one where I think we need to think about it a little bit and will probably work with Karen and Stan and Bill about all this stuff.
I don't know that anecdotal stories at this point are going to be particularly helpful. If we had a survey of the industry to really understand status and issues and all of that, I would consider it, especially an unbiased one. I would consider that to be useful.
I don't know personally that listening to isolated success stories -- you commented yesterday about trying to figure out whether somebody who was complaining was an isolated complainer or part of the majority, and it is the same thing about people who are successful.
Maybe the answer to this one is, I think others have referenced various industry studies, and maybe we need to get our hands on some of those industry studies to take a look at them and either look at them natively or get some sort of a presentation on them.
That may be a way to begin to get a slightly better feel of this. Right now we are sort of saying, I did it, well, no, I didn't. I don't think hearing more of I did it, I didn't is going to help us, really, in terms of the decisions we need to make.
Am I describing a reasonable next step on that one, which is trying to find some of the surveys that are being done.
DR. NAMINSCHON: The American Hospital Association had originally intended to testify yesterday, but they hadn't completed their analysis. It was also their survey. They wanted to know their next opportunity to testify. That is a possibility.
DR. ZUBELDIA: The Gartner Group has done a recent survey and Phoenix Health has been doing surveys.
DR. COHN: Let's get some of these together and take a look at them, either in written form or it may be that it would be most appropriate for us to ask for written comments, because we could easily spend all of the 26th taking written testimony on all the stuff that we need to be flexible.
MR. BLAIR: One thing that I would find extremely helpful is that the surveys that I have seen tend to just generically ask individuals whether they are going to be HIPAA compliant, but it doesn't get explicit.
Are they going to be compliant with the claims, the eligibility and enrollment transactions, or are they talking about security or are they talking about the other transactions.
I think that that is especially useful for those folks that say, no, they won't be. When they are saying no, they won't be, are they saying they are not going to be compliant with all of them, or is it just some of the transactions like the status of remittance transaction or something like that.
I think that is the kind of information that we really need if we are going to make a recommendation.
DR. ZUBELDIA: I agree. I think we need that level of granularity. Are they ready to dispense of local codes? Are they ready to use an identifier that has not been assigned by them, that sort of information.
DR. COHN: Since we are not, ourselves, doing a survey, you will have to rely on whatever information the surveyors found useful to ask. I think we will just have to screen it with those of -- as with any survey, one needs to be a little skeptical of the questions and the results. Richard, do you have a comment?
MR. LANDEN: I will make it brief. The survey, I think, is a great idea. There are success stories out there. We have heard first hand from segments of the industry that the way they see their reality is, they can't do it.
The survey can't just ask questions. We have to get into, are the factors that made certain entities successful, like UHEN, like Medicaid, like Medicare, are they replicable to the rest of the industry. If so, how. If not, why not, is there something different.
UHEN is probably an anomaly. They have been building a new system for seven years or so now, and they have got a limited number of partners. So, they have been able to do things that they started on pre-HIPAA, and I suspect they piggy backed on them.
The other question I would have is, what are some of the assumptions that these groups are making. I think you will find that some of the groups are assuming that they will be able to do certain things that are not necessarily 100 percent kosher with what is in the IGs.
You will find that they are implementing according to some companion documents that gives them a slightly different interpretation of what the standard is going to be or the standard content.
It is going and asking the tough questions and establishing the replicability of the factors that made these organizations successful in their claim to being HIPAA compliant.
DR. COHN: As I said, obviously we are time limited as well as staff effort. We are not a volunteer effort, but we are close.
MS. GREENBERG: I just wanted to report there is no meeting room in the Humphrey Building, so we are looking at the hotel for the 26th.
DR. COHN: I guess we could also, for that matter, if we need to we could go to one of the other government facilities. There are government buildings in Rockville, there are buildings in Hyattsville, et cetera, et cetera.
MS. GREENBERG: I think we will try to make it as convenient as possible. I don't think we want to start going to HCFA when we are staying at the Renaissance, although I love the HCFA cafeteria.
MR. NAMINSCHON: We would love to have you.
MS. GREENBERG: Thank you. Hopefully we can get a room at the hotel.
DR. COHN: I would certainly defer to you and thank you very much for your help on that. Now, I actually would like to, at this point, we haven't even made it through item one. Let's talk just very briefly about some of the issues for the rest of the year as well as a letter that I received. I think we will try to finish this up pretty quickly.
I have passed around issues for the subcommittee for the remainder of the year. Rather than, at this point, spending a lot of time going over it, why don't you just reflect on it and we will talk about it.
Probably, with the amount of work that we have to do between now and the 27th, this will be a reasonable topic for us to talk about during that breakout session on the 27th, along with the other letters.
As you know, these are issues. You may have others. You may think that some of these really don't need to be handled.
From my own view, by the end of the year, as I look forward, I think we do need to get into the code set issues, both holes in the transactions, terminologies, versus code sets, et cetera, et cetera. Reflect on them and see what else you think needs to be in there or what you think needs to be taken out of this list.
I will comment, we had sent out a notice to many of you. We are having you currently hold hearings. We are having a hearing in August regarding PMRI standards and hopefully also on some model issues.
In October we have tentatively scheduled dates and in December we have tentatively scheduled dates. We also asked you recently to hold dates for November.
I think we wanted just to get some feedback. Speaking of hearing about successes, there is actually a conference that is occurring in mid-November, the 12th through the 14th, in Orlando. I think it is the WEDI SNIPS success conference.
I think the question that has been brought up has been whether or not we ought to hold some hearings potentially as part of that, to sort of better understand, I think, this issue of successes.
Obviously the timing is not as great as we would have liked it to be. We would have liked to know that yesterday. I think that would certainly be a good environment potentially to understand both successes and issues and barriers that the industry is having.
I will tell you that my plan is not to hold hearings in October, November and December. We are going to be sort of juggling all of this. The question is, is this something that is of interest to the subcommittee members.
MS. GREENBERG: This is the WEDI meeting, which is like the week before?
DR. COHN: This would actually be a few days before.
MS. GREENBERG: My son is getting married Sunday. Yes, I know that week.
MS. FYFFE: I cannot participate.
MR. BLAIR: That would be of interest.
DR. ZUBELDIA: I will be at the WEDI meeting and I will be here.
DR. COHN: We are not going to make a decision on this today. I think we need to survey the other subcommittee members for their interest as well as identifying -- we can attend a meeting, which we obviously, as private citizens, can go off and do. It is a whole other thing to turn it into something that is useful for the work we are trying to do.
We need to sort of figure out what sort of hearings would make sense for us to journey down to Orlando.
Anyway, this is just for your information to think about. I think we will probably talk about it more in June.
Now, with that, let me make a comment about letters we have received about external code sets. Generally my thoughts about requests -- what is happening is that there are developers with external code sets that are used for particular purposes that were not named in the HIPAA reg.
A number of them are bringing forward comments, both directly to the NCVHS as well as I saw a couple of requests going through the DSMO process, for whether they should be named code sets.
Now, my own personal view -- I want to make sure we are all in agreement on this one, is in general, when we have been doing these, we have been referring them, at least initially, back to the DSMOs for some comment.
I don't know if they are the ones who make the final comments on all of these, but we feel they are very important input into whether or not these code sets should be named as part of the transactions.
Also, I think we will likely ourselves have hearings that will begin to look into some of those issues late in the year, early next year, to do a little more fact finding as part of that.
That is effectively going to be the answer I am going to give them, that we want them to explore DSMO process, we will be holding hearings toward the end of the year or the beginning of next year on these issues, and would obviously be asking them to testify at that point. Is this agreeable, that this is how we should be responding in these circumstances?
Okay, now are there any other issues coming before the subcommittee at this point?
DR. ZUBELDIA: I have a question. In some of the previous meetings we have talked about recommending to the Secretary to explore incentives for the implementation of HIPAA.
Harry mentioned yesterday that there is no prize for being first. Do we know if the Secretary is considering any prizes for early implementers?
MS. GREENBERG: Prizes?
DR. ZUBELDIA: Maybe tax rebates or deductions or something as an incentive for early implementers. Has the Secretary looked at anything?
DR. COHN: I have no knowledge of that. I think the question is whether we would want to recommend that in the letter.
MS. GREENBERG: Incentives, not prizes.
DR. COHN: We have a new Secretary of HHS. The Secretary has probably not reviewed every letter we have sent to previous secretaries. If, indeed, we think it is important, we ought to reflect on it and include it in whatever letter we are sending to the Secretary on these other issues, although it needs to be somehow consistent with overall what we are saying.
We can't say, gee, you ought to delay and you ought to give incentives. It needs to be somehow a letter that is internally consistent.
MS. GREENBERG: We don't normally give prizes for obeying the law.
DR. ZUBELDIA: Maybe incentives for early implementation ahead of the mandated schedule. Maybe there should be an incentive for being first.
What we are running into is the chicken or the egg. Who is going to be first? Nobody wants to be first.
DR. COHN: Kepa, I would have you think about that one and further develop a proposal. I think we are willing to consider it as a subcommittee, although I would have to be convinced that it actually helped with an early successful implementation as opposed to just being something. So, think about that.
Anyway, does anybody have any other comments they want to share with the committee, any other issues we need to bring forward?
I recognize that the last couple of hours have not been easy and obviously we are dealing with, I think, some very difficult issues right now.
We want to thank the subcommittee for their forbearance as we have tried to stumble through issues that are, I think, perplexing the entire industry right now.
Certainly I am hoping that, with some days of enlightenment and carefully reading of the testimony, as well as just some introspection and thought, that we may come up with some useful recommendations to the Secretary to help ensure an early successful implementation which is, at the end of the day, what we are all here about.
With that, we will adjourn until hopefully June 26, I believe it is, Tuesday, and we will start, I would presume, some time between 9:00 and 9:30 in the morning. Thank you, everyone.
[Whereupon, at 12:15 p.m., the meeting was adjourned.]